Speaker Biographies

Dr. Frank Agbogbo has over 18 years of experience in process development, biotechnology, gene, and cell therapy industries. He is currently the Vice President of Process Development at Forge Biologics, responsible for rAAV process development and plasmid DNA production. Previously, Dr. Agbogbo was the Senior Director of Process Development at Cytovance Biologics for over 7 years where he took increasing responsibilities as Director of Process Development with oversight responsibilities over the Upstream and Downstream teams. Frank’s experience includes process development, Design of Experiments (DoE), process optimization, process characterization, and scale-up from R&D to manufacturing (cGMP and non-cGMP). He has co-authored over 15 peer-reviewed publications and contributed to 5 patents. He holds a Bachelor of Science in Chemical Engineering, PhD in Chemical Engineering from Texas A&M University, College Station, TX, and an MBA with a certificate in Entrepreneurship from the Price College of Business, Oklahoma University, OK.

UKZN’s Professor Fernando Albericio received a Lifetime Achievement Award at the European Peptide Synthesis Conference (EPSC) 2024 in the Czech Republic for his outstanding contributions to the peptide synthesis community. Albericio has published more than 900 papers, co-authored four books, filed over 60 patents, and supervised or co-supervised more than 80 PhD students and more than 100 master’s students over his almost 50-year career.

Andrea Arsiccio is a Senior Scientist leading the in silico team at Coriolis Pharma, where he is implementing innovative modelling concepts for biopharmaceutical formulation and drug product development. He received a master's degree in Chemical Engineering in 2016 followed by a PhD degree in 2020. During his PhD he investigated the computational modelling of proteins, with a special focus on the formulation of biopharmaceuticals. He subsequently worked as a Postdoctoral scholar at the University of California in Santa Barbara and at Politecnico di Torino, and during this time his research focused on molecular dynamics simulations and bioinformatics. His main interests and expertise are in the fields of modelling, protein folding and aggregation, and freeze-drying.

Dr. Eduard Ayuso is the CEO of Siegfried DINAMIQS, a CDMO providing manufacturing services, process development, quality control and analytics solutions. He also served as chairman of the Manufacturing committee of the European Society for Gene and Cell Therapy. He is an expert in the field of gene therapy using viral vector platforms, including their design, manufacture, and purification. He was previously the CTO at DiNAQOR, a genetic medicine platform company. He also served as Head of Innovative Vectorology at INSERM, and as the Scientific Director of the Translational Vector Core at the University of Nantes. Dr. Ayuso earned his Ph.D. in Biochemistry and Molecular Biology and his degree in Veterinary Medicine from the Autonomous University of Barcelona.

Prof. Dr. Janina Bahnemann is a Full Professor and the Department Head of "Technical Biology" at the University of Augsburg, Germany. She studied Life Sciences at Leibniz University Hannover (2004–2009) and earned her PhD from Hamburg University of Technology in 2014. In 2015, she joined the California Institute of Technology (Caltech, USA) as a postdoctoral fellow. From 2017 to 2022, she led an independent Emmy Noether Junior Research Group at Leibniz University Hannover, focusing on microfluidic systems for cell culture applications. She also held a substitute professorship at Bielefeld University (2021–2022). Her research centers on the development and integration of 3D-printed microfluidic systems and biosensors for applications in biotechnology and biomedicine.

Dr. Maria Barreira Gonzalez is a scientist with over 18 years of experience in molecular and cellular biology, including the last decade dedicated to cell and gene therapy. She holds a BSc in Biology from the University of Oviedo (Spain) and a PhD from the University of Salamanca (Spain), where she investigated oncoprotein regulation in cancer. Following her doctoral studies, she joined the University of Cambridge (UK) as a postdoctoral researcher, focusing on gene regulation and epigenetics during mouse embryo development. In 2016, Dr. Barreira Gonzalez became a Senior Scientist at Touchlight Genetics Ltd. (UK), applying synthetic DNA technology to cell and gene therapies, which led to patents, peer-reviewed publications and the development of new DNA products. She joined the Cell and Gene Therapy Catapult (UK) in 2021 as Lead Scientist, where she spearheaded projects on viral vector manufacturing innovation, with a particular focus on recombinant Adeno-Associated Virus (rAAV) bioprocessing and analytics, collaborating extensively with academia, biotech, and pharmaceutical partners. She is currently Programme Head of Gene Modification at the Cell and Gene Therapy Catapult, leading a strategic, high-impact gene therapy portfolio spanning viral and non-viral delivery systems, in vivo applications, and gene editing technologies. In this role, she drives innovation, scale-up, and global collaboration to accelerate the translation and commercialization of gene therapies for patient benefit worldwide.

Mark is the leader of upstream process development at Purespring Therapeutics and has 15 years of industrial experience within the cell and gene therapy sector. Mark leads a team of experienced scientists within the viral gene development, delivering robust manufacturing processes, supported by rapid, high-resolution characterization tools to enhance the production of AAV based gene therapies. Mark's team also supports the development of new adaptive manufacturing approaches by integrating technologies to allow real-time product monitoring and enable feedback control during product manufacture. Prior to his work at Purespring, Mark spent 7 years at the Cell and Gene Therapy Catapulting supporting the development of ATMP processes suitable for GMP as well as consulting for the Janssen group advising on the manufacture of its lead ocular gene therapy.

Prof. Sonja Berensmeier has led the Bioseparation Engineering Group at the Technical University of Munich since 2009. Previously, she worked as a group leader at the Karlsruhe Institute of Technology in the area of biofunctional surfaces. She meets the challenge of integrating molecular biology, biotechnology, particle technology, and process engineering. Her current research focuses on process intensification by adsorptive and extractive separation methods. In the field of adsorbents, she specializes in magnetic and conductive materials and their translation into new process designs. Berensmeier gained international experience at MIT, ETH, and Iowa State University. She is well established in the scientific community and is a member of the scientific committees of the international conferences PREP and ISPPP.

I have a BSc in Energy and Process Engineering (2019) from the Technical University of Berlin and an MSc in Chemical and Biochemical Engineering (2022) from Denmarks Technical University. From 2022, I have held a position as a Development Engineer at Novo Nordisk and in 2025 I have started my Industrial PhD program in Novo Nordisk's Downstream Development department in collaboration with Lund University.

Harsha Reddy Borra is a bioprocessing leader with over 18 years of experience in biologics development and manufacturing, spanning monoclonal antibodies, complex proteins, and advanced therapies such as viral vectors. He currently serves as Process Development Lead at Accord Healthcare, where he oversees bioprocess development and leads external manufacturing activities to support regulatory submissions and technology transfer to clinical and commercial manufacturing. Harsha played a crucial role in establishing a Biopharma Centre of Excellence lab that accelerates biologics development through the implementation of process automation, advanced analytics, and digital tools. His expertise includes establishing platform processes, applying advanced statistical and modeling approaches for process optimization, and integrating PAT strategies to drive efficiency and regulatory compliance. He has contributed to multiple biosimilar and novel biologics programs, supporting global commercialization efforts while building high-performing teams and advancing innovation in sustainable biomanufacturing.

Vicent holds a Bachelor in Chemistry from the University of Valencia, and Master and PhD in Theoretical Chemistry and Computational Modelling from the Toulouse III – Paul Sabatier University and the Autonomous University of Madrid, respectively. During his PhD, he focused on the development of computational chemistry programs to describe the photoionization of molecules after their interaction with ultrashort laser pulses. After his PhD, he joined the R&D department of Qnami AG to contribute to the implementation, automatization and testing of new quantum measurement protocols for the room temperature scanning NV (nitrogen-vacancy) center microscope. In September 2024, he joined the Bioprocess Technology Laboratory at the University of Applied Sciences Northwestern Switzerland (FHNW). He focuses on the development of ready-to-use calibration models for the application of Raman spectroscopy in bioprocesses

Christopher founded Consulting on Advanced Biologicals Ltd. at the end of 2009, in order to focus his activities within the Regenerative Medicine sector. Advbiols Ltd. provides EU regulatory services to the regenerative medicine industry in addition to business and regulatory research and analysis to identify and focus on the real barriers to commercialisation of regenerative medicine. Christopher has a PhD in xenotranplantation immunology and spent 8 years in biotech (Imutran Ltd., a Novartis Pharma AG Co., and Intercytex) before joining the MHRA as a quality (CMC) assessor (biologicals and biotechnology unit). During this time, Christopher was involved with national implementation of the new Advanced Therapies Regulation and also involved through his participation in the CHMP’s cell products working party (CPWP) in implementation at the EMA level including drafting guidelines.

Michael Butler is a Principal Investigator in Cell Technology at the National Institute of Bioprocessing Research & Training (NIBRT), Ireland, Adjunct Full Professor in University College Dublin as well as Distinguished Professor Emeritus of the University of Manitoba, Canada. He holds degrees in Chemistry and Biochemistry from the Universities of Birmingham, London (UK) and Waterloo (Canada). He was the scientific director of MabNet, a Canadian network for Mab production and founder of Biogro Technologies Inc., a spin-off company dedicated to serum-free media development. His research work focuses on the development of bioprocesses using mammalian cells for the production of recombinant proteins, monoclonal antibodies and viral vaccines.

Prof. Dr. Johannes Buyel is a biotechnologist and bioprocess engineer and by training and received his Bachelor of Science from the RWTH Aachen University in Aachen (one of Germany´s Excellence Universities) in 2006. He continued his master studies in Molecular Biotechnology with stays abroad in Sweden (Lund University, ERASMUS schoolarship) and the USA (Fraunhofer Center for Molecular Biotechnology, Newark, Delaware). Finishing his Masters with honours in 2009 he was awarded the Springoroum Coin. Johannes conducted his PhD at RWTH Aachen University during which he was a visiting scientist at the Rensselaer Polytechnic Institute (Troy, NY, USA) and Karlsruhe Institute of Technology (KIT) (Germany) for several months. He received his PhD with honours and was awarded the Borchers Medal. In 2014 he joined Fraunhofer IME as a group leader and became head of the Bioprocess Engineering department the year after. In parallel, Johannes started a second PhD in Bioprocess Engineering at the KIT, which he finished in 2017. Between 2018 and 2020 he conducted his habilitation and was an Associate Professor at the RWTH between 2020 and 2023. Johannes is an active member of the German Biotechnology Association (DECHEMA), and member of the Editorial Boards of Frontiers in Bioengineering and Biotechnology, Frontiers in Plant Science as well as Transgenic Research, where he is Editor-in-Chief since 2021. In 2022, he joined the University of Natural Resources and Life Sciences, Vienna (BOKU) as a Full Professor for Downstream Processing. Johannes has 15+ years of experience in the development of tailor-made upstream production and downstream processing for 50+ recombinant proteins, small molecules and DNA in different expression systems such as E. coli, yeast, plant cell cultures and whole plants both under GMP and non-GMP conditions. He is also focussing on integrated processing, i.e. the use of residual biomass for cascading use. Johannes was/is involved in international projects like PHARMAPLANT, FUTURE-PHARMA and RESILIANCE. Amongst others, he received a €2.5 million Fraunhofer Attract grant for a project to establish a model-driven high-throughput expression and purification platform for recombinant proteins (FAST-PEP). Johannes was a principal investigator (PI) in the tumor-targeted drug delivery graduate school of the German Research Foundation (DFG; 2018-2022) as well as the International Center for Networked Adaptive Production (ICNAP; 2016-2022) for which he has so far received funding of €0.9 million and €1.8 million respectively. His work is strongly inter- and cross-disciplinary, combining research in, for example, biotechnology, bioprocess engineering, informatics, mathematics, data science, oncology, cosmetics and nutrition. He has currently more than 80 publications (h-index 27, i10-index 51, 2333 citations as of August 2023).

Leading the Legend Biotech organization in Ghent (Belgium) where we have 2 production facilities for Carvykti. 25 years progressive experience in all GxP areas and worked in commercial manufacturing environments, ranging from Aseptics, Large and Small Molecules, Cell and Gene, and Radioligand therapies as well as in the R&D environment. Passion to work with and develop people in a multicultural environment, drive collaboration and continuous improvement.

Giovanni serves as Senior Market Segment Manager at Hamilton Bonaduz AG's Process Analytics Business Unit. He specializes in business development across Biotech, Pharma, and Food sectors. His multifaceted role spans product strategy & development, sales coaching, and hands-on customer support. As a GMP coach, Giovanni guarantees that process analyzers align with key regulations, including GAMP 5 and CFR 21 Part 11. With his efforts, he contributes to Hamilton Process Analytics' mission: pioneering sensor technologies to solve biopharma challenges.

Vered Caplan, CEO Orgenesis Inc., a global biotech company working to unlock the full potential of cell and gene therapies in an affordable and accessible format at the point of care. Orgenesis identifies promising new therapies and leverages its POCare Platform to provide a rapid, globally harmonized pathway for these therapies to reach and treat large numbers of patients at lowered costs through efficient, scalable, and decentralized production. Prior to Orgenesis, Vered has been CEO of Kamedis, a company focused on utilizing plant extracts for dermatology purposes. From 2004 to 2007, Ms. Caplan was CEO of GammaCan, a company focused on the use of immunoglobulins for the treatment of cancer. During the previous five years, Ms. Caplan has been a director of numerous companies in the biotech industry, among them: Inmotion Ltd., a company involved with self-propelled disposable colonoscopies; Nehora Photonics Ltd., a company involved with non-invasive blood monitoring and others. Ms. Caplan has a M.Sc. in biomedical engineering from Tel Aviv University specializing in signal processing; management for engineers from Tel Aviv University specializing in business development; and a B.Sc. in mechanical engineering from the Technion-Israel Institute of Technology specialized in software and cad systems.

Pinar Carkci has been working for the Japanese company Asahi Kasei Bioprocess for 8 years. She is a specialist in virus removal filtration. Within Asahi Kasei Bioprocess, Pinar is the Senior Product Manager in charge of technical support and business development in Europe. Before joining Asahi Kasei Bioprocess, she worked for Tosoh Bioscience, giving technical and scientific support for diagnostic systems as a Junior Application Specialist.

Pinar obtained her bachelor’s degree in biomedical laboratory technology at the University of Applied Sciences KhLim, located in Belgium.

I joined CPI in 2021 and I am currently the Technology Director at the Medicines Manufacturing Innovation Centre. I have responsibility for creating and delivering our portfolio of medicines manufacturing innovation projects across areas such as clinical trial supply, personalized medicines, and oligonucleotide and peptide manufacturing. Prior to CPI, I spent 21 years working for GSK in pharmaceutical manufacturing, mostly in technical leadership roles, including over 10 years as Technical Director at a manufacturing site. I have a BSc in Biotechnology from the University of Birmingham and PhD from the University of Sheffield.

Dr. Ayca Cankorur-Cetinkaya is a Senior Scientist at AstraZeneca, specializing in upstream process development for biopharmaceutical manufacturing. With over a decade of experience in the optimization and advancement of upstream processes, Dr. Cankorur-Cetinkaya has played a pivotal role in the development and technology transfer of CHO cell line-based platforms for the manufacture of diverse therapeutic modalities under GMP conditions, supporting the progression of early-stage clinical studies. Dr. Cankorur-Cetinkaya earned her PhD in Chemical Engineering from Bogazici University in Istanbul, where her research focused on Systems Biology. She is the author of more than ten peer-reviewed publications and is recognized for her commitment to scientific collaboration and innovation. Passionate about integrating systems biology principles into upstream process development, she leads multidisciplinary teams dedicated to advancing manufacturing strategies in alignment with evolving biotherapeutic technologies.

Dr. Cheng is a protein scientist with extensive experience in therapeutic protein discovery and development, specializing in purification, characterization, and engineering of complex biologics. He received his Ph.D. in Biochemistry from the University of Delaware, where he trained in protein chemistry and mass spectrometry. He began his industry career at NGM Biopharmaceuticals, where he worked on multiple innovative bispecific antibody and hexameric IgG programs as part of the biologics team. In 2025, he joined Juvena Therapeutics as a principal scientist in protein science, advancing early-stage AI drug discovery platforms. Currently, he serves as a principal scientist at Immunedge, where he leads efforts in the design, production, and characterization of next generation therapeutics. His expertise spans antibody engineering, purification process development, and biophysical characterization, with a strong focus on translational research in biologics.

Véronique Chotteau, Professor, Leader of the Cell Technology group, Dept. Industrial Biotechnology, School of Engineering Sciences in Chemistry, Biotechnology, and Health, KTH (Royal Institute of Technology), Stockholm, Sweden; Education: BSc Eng. Sciences, MSc Electrical Engineering, MSc Biotechnology, PhD Automatic Control/Modelling/Biotechnology (University of Louvain, Belgium); V. Chotteau has 30 years of experience in mammalian cell culture including more than 10 years in biopharmaceutical industry (at Pharmacia Upjohn/Biovitrum, Stockholm, nowadays Swedish Orphan Biovitrum). She is the Director of AdBIOPRO, Centre for Advanced Bioproduction by Continuous Processing, and Coordinator of iConsensus, EU IMI2 project. She joined KTH in 2008, when she was offered to lead the animal cell cultivation activities. Her group is focusing on cell-based processes for biologics production, high cell density perfusion of CHO and HEK293 cells, mathematical modelling, and production of viral vectors. Her group was the first to publish cell densities higher than 200 millions cells/mL in CHO cell perfusion process.

Colin Clarke holds a MSc and PhD in Bioinformatics from Cranfield University, UK. He leads the Bioinformatics and Data Analytics Laboratory at the National Institute of Bioprocessing Research and Training, Dublin, Ireland and is an Associate Professor in the School of Chemical and Bioprocess Engineering at University College Dublin. The goal of Colin’s systems biology research is to enhance our understanding of CHO cell factories to enable more efficient production. Colin’s team also have an active research programme focussed on harnessing big data technologies for biopharmaceutical manufacturing. He was awarded the Martin Sinacore Outstanding Young Investigator Award at Cell Culture Engineering in 2014 and selected as the Young Leader of the Year at the 2017 Irish Laboratory Awards.

Dr. Ana Sofia Coroadinha has a Degree in Biochemistry (University of Lisbon) and a PhD in Gene Therapy performed at Généthon, Helmholtz Centre for Infection Research (HZI) and iBET, granted in 2005 by ITQB-UNL. Since July 2009 is the Head of Cell Line Development and Molecular Biotechnology Lab at iBET and ITQB-NOVA. She has over 20 years of experience in recombinant viruses and animal cell culture, areas where she has published over 50 peer reviewed papers. Dr. Ana Sofia Coroadinha group research focus on applied virology developing recombinant virus and molecular tools supporting the areas of gene therapy, vaccine development and virology.

Ricardo Correia is a Biological Engineer from IST (Portugal), graduated in 2014. From 2015 to 2017, he was a junior researcher at the Animal Cell Technology at iBET / ITQB-NOVA (Portugal), being involved in the upstream processing of a universal Influenza vaccine candidate. Ricardo got his PhD degree within the MIT Portugal - Bioengineering Systems doctoral program in 2022, working at iBET / ITQB-NOVA. He is author of 16 scientific manuscripts in peer-reviewed journals, has supervised 4 MSc and 2 PhD students, made 5 oral communications and >10 poster communications. His research focuses on the development of novel bioprocess engineering approaches for the improved production of vaccine candidates against infectious diseases such as Influenza and malaria.

Dr. Hagen Cramer is a renowned expert in all chemistry-related aspects of oligonucleotide therapeutic development. He has been working in the biotech industry for over 20 years spanning discovery, development, and manufacturing of oligonucleotide-based therapeutics. Early in his career, he worked with Gemini Technologies and Ridgway Biosystems on the discovery of 2-5A antisense for the treatment of a variety of cancers and viral diseases. In 2005, he joined Girindus, which was later acquired by Nitto Denko Avecia, where he headed the process development department, eventually becoming Director of Operations. More recently, he joined Wave Life Sciences where he was responsible for securing drug substance and drug product for its clinical pipeline of stereodefined oligonucleotide therapeutics. In 2020, he joined QurAlis as Chief Technology Officer supporting all programs targeting diseases affecting the CNS.

Dr Greta Csalane Besenyei is a Purification Development Scientist at AstraZeneca (UK) focusing on accelerated early-stage development for complex multi-specifics. She applies mechanistic modelling, automated scale-down workflows, and parallel clone evaluation to define design spaces, improve yield, enhance impurity control, and de-risk scale-up under material and timeline constraints. Greta holds a PhD in Biochemical Engineering from UCL. Her session, Mechanism-Driven Momentum, showcases a rapid, insight-driven path to GMP for a next-generation biologic, highlighting predictive operating envelopes and quantitative setpoint rationale.

Upstream process development and design for the efficient production of recombinant peptides and proteins as well as plasmid DNA in bacterial cells for bio-pharmaceutical, industrial and environmental applications; fusion protein technology, especially in Escherichia coli, for integrated bioprocess design; advanced process and systems characterization; production of peptides containing non-canonical amino acids to improve their biopharmaceutical properties.

Robin Curtis joined the Chemical Engineering and Analytical Science School at University of Manchester in 2003. Previously he did his PhD at the University of California at Berkeley and postdoctoral training at University of California Los Angeles and Rice University. His current research is focused on understanding the fundamentals of protein solution behaviour with an emphasis on elucidating non-specific protein-protein interactions and how they depend upon protein structural properties and the solution components including excipients. The approach relies on using a combination of light scattering methods (dynamic and static light scattering, electrophoretic light scattering) as well as computational approaches based on structural informatics and molecular modeling. Current projects are focused on elucidating the molecular determinants of protein phase separation, developing novel excipients to prevent protein aggregation, and measuring protein-solvent interactions.

Claudia Cuscona is an experienced Upstream and Fluid Management Specialist with a strong background in pharmaceutical field. She holds a degree in Biology and began her career with years of fundamental research in laboratory settings, gaining strong analytical and scientific skills. Following her research experience, Claudia spent years in Chemistry, Manufacturing, and Controls (CMC) project management for cell and gene therapy, where she coordinated complex projects and contributed to innovative therapeutic solutions. Currently, Claudia focuses on optimizing upstream operations in pharmaceutical productions to intensify yields and productivity, combining her scientific background with operational expertise. She is passionate about sustainable practices and advancing technologies that support her job every day.

Michaela Dehne studied Life Sciences at Leibniz University Hannover (LUH), Germany. During her master's program, she completed a six-month internship at Northeastern University Boston, USA, where she investigated the virulence of Acinetobacter baumannii in Caenorhabditis elegans as model organism. She is currently in the final stages of her doctoral studies, jointly supervised by Prof. Dr. Janina Bahnemann (University of Augsburg, Germany) and Prof. Dr. Thomas Scheper (LUH, Germany). Her research focuses on the development of 3D-printed microfluidic systems for transient transfection and cell retention in continuous perfusion bioprocesses. In addition to her academic work, Michaela serves on the board of the Bioprocess Engineering Division of DECHEMA and is a recipient of the Joachim Herz Foundation Add-on Fellowship, which supports her research and professional development.

Duygu is an Associate Professor in Digital Bioprocess Engineering at UCL. Her research focusses on the use of automation, modelling, data management, analytics and statistics in systems bioprocess engineering and systems biology. Her group develops tools and pipelines to address specific digitalisation and data related challenges concerning bioprocess industries.

I am a mAb purification scientist with 5 years of experience in MSAT, specializing in the development, optimization, and transfer of monoclonal antibody purification processes. At Sanofi, I drive lifecycle management and process robustness initiatives, lead technology transfers, and provide support for manufacturing, validation, and regulatory submissions. My career has given me hands-on expertise from lab and pilot-scale development through to large-scale implementation. I particularly enjoy working transversally with cross-functional teams to deliver robust, compliant, and efficient bioprocesses.

Dr. Elena Dominguez Vega received her Ph.D. degree on analytical chemistry in 2011 at the University of Alcala (Spain). After joining the Biomolecular Analysis group at Utrecht University (The Netherlands) in 2012, she worked on the development of new electrophoretic methods for the analysis of biopharmaceuticals. In 2013 she continued as postdoctoral researcher at VU University where she focused on the study of protein heterogeneity, conformation and affinity. In May of 2017, Dr. Dominguez Vega joined the Center for Proteomic and Metabolomics at the LUMC as assistant professor were she continue her work on the characterization of glycoproteins of clinical and pharmaceutical interest. Furthermore she has expanded her research focus to the development of innovative analytical platforms for the analysis of gene therapy products. Over the years, Dr. Elena Dominguez Vega has closely collaborated with several pharmaceutical companies and has received multiple grants and awards in support to her research.

Leading Novasign as CEO, Mark is passionate to improve bioprocesses for the production of biopharmaceuticals, enzymes and substitutes for animal-derived proteins. With his team, he is developing a hybrid modeling software for both up and downstream processes. This software utilizes artificial intelligence applied to process data and first principle models (hybrid models) to not only accelerate bioprocess optimization but also to reuse these models for model predictive control strategies. The company Novasign was founded in 2019 offering this unique software solution which is already in use by several TOP25 pharma companies to also accelerate their process development.

After completing a mathematics degree, Joe started his career as a mathematical modeller at Public Health England. Following 11 years at this government-based institution, Joe completed his PhD in mathematical modelling of T cell activation at the University of Southampton. Joe then completed a 3-year post-doctoral research position in the Department of Biochemical Engineering at UCL where he developed digital shadows for cell therapy applications. Joe currently holds an Honorary Senior Research Fellow position at UCL, and he is also a Research Associate at Teesside University. Working with colleagues from both institutions, Joe continues to develop predictive models to help improve the manufacture of cell therapies.

After completing Biotechnology studies at TU Braunschweig in 2007, I began my career in upstream cell culture development at Roche Penzberg, initially focusing on media development. In 2010, I moved to Novartis Basel, continuing in upstream cell culture development and focusing mainly on early phase processes and process intensification. Over the years, I supported process development for different molecule formats, including bi-specifics, tri-specifics, Fc fusion proteins and other recombinant therapeutic proteins. More recently, I drove the establishment of an innovative and efficient development platform for multispecifics, focusing on the creation of new strategies that streamline and accelerate the development of these complex modalities in a rapidly evolving environment.

Jose Escandell is a Principal Scientist at the Animal Cell Technology Unit of iBET’s Health & Pharma Division, where he has been working since 2019. His research focuses on streamlining cell line development and optimizing production systems through cell engineering approaches, with a particular emphasis on recombinant adeno-associated virus (rAAV) and antibody production platforms. At iBET, he has contributed to the development of scalable rAAV production platforms and sensitive analytical methods for bioprocess monitoring. He completed his pharmaceutical studies in 2002 and earned an MSc in Pharmacology and Drug Discovery in 2004 at the Universitat de València, Spain. He obtained his doctoral degree in 2008, investigating the anticancer and anti-inflammatory properties of natural compounds. His postdoctoral research at the CRUK/MRC Institute for Radiation Oncology at the University of Oxford focused on DNA damage repair and cancer biology. His career includes participation in more than 40 scientific meetings and authorship of 23 publications in high-impact journals such as Nature Structural & Molecular Biology, EMBO, and Nature Communications. His work has received over 1500 citations and he holds an H-index of 14. He has led two FCT-funded projects as principal investigator and is a recipient of a Marie Curie Fellowship (2014) and an FCT Investigator Award (2020).

David Estapé is a seasoned biotechnology expert with a Ph.D. in Chemical Engineering and 25 years of experience in facility design and GMP consulting across the biotech, vaccine, blood plasma, and ATMPs sectors. Having contributed to major biotech projects worldwide, from start-ups to leading pharmaceutical firms, David has a deep interest in emerging technologies and regulatory trends. He actively engages with organizations such as BioPhorum and the International Society for Pharmaceutical Engineering (ISPE). Currently, he serves as the Technology Manager at CRB’s Basel office in Switzerland.

Lara Fernandez Cerezo graduated from University College London with a Master of Engineering in Biochemical Engineering in 2014. She then pursued an Engineering Doctoral degree, a 4-year industrial PhD program with Merck focusing on scale-down filtration technologies of high concentration mAbs. Upon graduation, she established the ambr crossflow high throughput system as a process characterization/development UF/DF tool in the Merck process development teams. In 2019 she transitioned to continuous manufacturing (CM) in biologics gaining ‘hands-on’ experience in both non-GMP 50L development scale and GMP 500L clinical scale. Since moving back to the development group in the US in 2021, Lara continues to influence the GMP continuous manufacturing teams at Merck by providing recommendations for the design of our next-generation commercial CM facility including a customized SPTFF/ILDF Skid. Lara now spearheads novel downstream biologics continuous manufacturing projects in the Enabling Technology group at Merck.

Bastian Franke works at Numab Therapeutics AG as a group leader USP/DSP and leads a team of research associates responsible for the manufacturing of multispecific antibody-based therapeutics, process development and technical transfer to C(D)MOs, as well as implementation of automated and novel purification workflows. Prior to Numab he gained first industry experience at DSM as a scientist in downstream processing after a postdoctoral fellowship at the University of Basel, Switzerland, where he developed novel isotopic labelling techniques for NMR applications and automated multicolumn purification schemes in collaboration with Cytiva. Bastian Franke received his PhD in structural biology from the University of Queensland, Australia.

Matthias Franzreb (b. 1963) received his Ph.D. in Chemical Engineering from the University of Karlsruhe in 1992. His doctoral research focused on ion exchange technology and included a research stay at Penn State University, State College, USA, under the supervision of Prof. Fred Helfferich. He subsequently joined the Karlsruhe Institute of Technology (KIT), where he initiated work on magnetic micro-adsorbents and their application in large-scale magnetic separation processes. In 2002, he completed his Habilitation, and in 2009, he was awarded an Extraordinary Professorship by KIT. Since 2014, he has served as Associate Director of the Institute of Functional Interfaces at KIT. His research focuses on novel bioseparation techniques, electrobiotechnology, and bioprocess modelling. His current work emphasizes the development of digital twins—both material- and process-based—and the setup and integration of autonomous self-driving laboratories in bioengineering.

CMC consultant at Inits Consulting with extensive expertise in analytical sciences. He brings over 10 years of experience in research and analytical development for biological products, including ATMPs and antibodies. For the past two years, Yann has supported biotech companies in CMC project management, analytical strategy development, assay validation, troubleshooting, and comparability studies, helping to ensure robust and compliant product development.

Lukas Gerstweiler is a lecturer in Bioprocess engineering at the School of Chemical Engineering at the University of Adelaide, Australia. He is currently establishing the biomanufacturing research group focusing on efficient manufacturing of biopharmaceuticals such as Virus-like particles, mRNA and recombinant proteins. The research focus is on continuous multi column chromatography, process modeling, process integration and better purification pathways.

Francesc Gòdia, PhD in Chemistry from the Universitat Autònoma de Barcelona (UAB) and professor of Chemical Engineering at the same university, was recently elected as the new president of the European Federation of Biotechnology (EFB), of which he was already vice-president. Gòdia's research activity focuses on the development of bioprocesses for the production of biopharmaceuticals, vaccines and viral vectors for gene therapy using animal cell culture and on the development of regenerative life support systems in space. He is director of the MELiSSA pilot plant, a unique European Space Agency facility on the UAB campus. The EFB is a non-profit federation of European biotechnology-related scientific societies, academic institutions, companies and individual professionals. Its goal is to promote international, multidisciplinary and cross-disciplinary collaboration within and outside Europe with the aim of contributing to making advances in biotechnology reach society. The EFB organises multiple international congresses, workshops and symposia, such as the European Congress of Biotechnology. The official scientific journal of the Federation is New Biotechnology.

Dr. Christoph Gstöttner obtained his PhD in 2021 at the Leiden University Medical Center (Netherlands) under the supervision of Prof. M. Wuhrer. His PhD research was focused on the development of electrophoretic but also chromatographic methodologies for the in-depth characterization of biopharmaceuticals such as monoclonal antibodies or newer antibody formats. In his postdoc, he focuses on the development of new CESI-MS methods for the functional characterization of biopharmaceuticals and their affinity to Fc receptors.

Jahid is a Programme Head of Cell Delivery with 10 years of experience at the Cell and Gene Therapy Catapult. He has extensive experience developing processes across cell and gene therapy and leads the development of automated differentiation processes on the Allogeneic Cell Therapies programme. Jahid specialises in bioprocess translation with a strong focus on process automation and scale-up. His background is in Biochemical Engineering and he has a PhD in Tissue Engineering from the University of Leeds which focused on the decellularisation of porcine bone-meniscus-bone for use as a meniscal replacement.

Simon Hawdon has over 30 years’ experience in the Biotechnology industry in the UK, working for organisations such as Lonza and Merck Millipore. Now Chief Technologist at CPI working in downstream processing with a particular passion for process intensification and sustainability. He has been actively involved in a broad range of projects involving the optimisation of purification strategies for mRNA based therapeutics. Active collaboration is a feature of the projects he has been involved with. He has worked with a variety of collaborative partners ranging from SMEs to large Pharma and Biotech companies

Hooman Hefzi is an Associate Professor at the Technical University of Denmark leading the Advanced Mammalian Cell Engineering group. The group’s focus is optimizing biologics production through data-driven improvements to host cell lines, leveraging high-dimensional omics data and AI/ML classifiers for target identification. Previously, he led the Omics and Modeling Team in Biologics Technical Development at Biogen. Hooman received his Ph.D. in Dr. Nathan Lewis’s lab at UC San Diego.

Dr. Hwang is a Scientist 4 at Genentech in the Peptide Therapeutics team under the Early Discovery Biochemistry department. She received her Ph.D. from Duke University, where she studied and investigated epigenetic protein-protein interactions, and completed her postdoctoral training at Stanford University, leading and developing small molecules for engineering protein dynamics. Since joining Genentech in 2019, she has investigated various signaling pathways involved in disease pathogenesis using peptides as a tool. She currently focuses on the identification and development of disulfide-constrained peptides (DCPs) using phage-display technology, supporting pipeline projects at Genentech, and the bioproduction of DCPs using the E. coli system to support DCP research.

Maximiliano Ibaceta is a Civil Engineer and M.Sc. from the Pontificia Universidad Católica de Chile with a decade of international experience in bioprocess development, spanning early-stage R&D to large-scale production and commercialization of bio-based materials. He currently serves as Chief Scientific Officer at the Vienna Textile Lab while simultaneously pursuing his Ph.D. at TU Wien. His work focuses on generation of mechanistic knowledge and the development of real-time parametrization methods for estimation and optimal control of bioprocesses, with the clear objective of contributing to the future of the bioeconomy.

Dr. Jared Isaac has worked in the biotechnology field for 13 years. He is Director of Chromatography and Mass Spectrometry at Cygnus Technologies. He works with Biopharmaceutical companies to perform antibody coverage coverage analysis by AAE, LC-MS and 2D-PAGE. His passion is the development of absolute and relative LC-MS quantification methods for HCPs to guide process development and elimination.

Lennart Jacobtorweihe studied molecular biotechnology at the University of Bielefeld. During his PhD at the Max-Planck-Institute in Magdeburg, he focuses on the upstream processing of oncolytic viruses in cell culture.

Camille Jenny graduated with a Master of Science in biotechnology from ENSTBB-Bordeaux INP (Biotechnology graduate school of Bordeaux) in October 2023. During her studies, Camille took a gap year to work on cation exchange chromatography mass spectrometry in the Analytical Characterization department of Novartis Pharma in Basel. After a 6-months internship focusing on the development of skin models in Singapore, Camille returned to François Griaud's lab as a Postgraduate in mass spectrometry, currently working on cyclic ion mobility separation and ECD fragmentation techniques.

Thomas is an academic member of staff at UCL Biochemical Engineering, focusing on the characterisation and design of advanced downstream bioprocessing materials.

Professor Alois Jungbauer received his PhD in Food Technology and Biotechnology from the University of Natural Resources and Life Sciences Vienna, Austria 1986. He serves since then as a professor at the Department of Biotechnology. He teaches Protein Technology and Downstream Processing and Bioprocess Engineering. He also acts as area head and Deputy Director of Research in the Austrian Centre of Industrial Biotechnology. He is currently working in the field of bioengineering of proteins, plasmids and viruses with special focus on expression, downstream processing and characterization of large biomolecules. For more than 10 years he is working on continuous manufacturing of biopharmaceuticals. As a proliferate researcher he has more than 340 publications on recombinant protein production and bioseparation, 17 patents and 12 book contributions and recently a monograph entitled “Protein Chromatography , Process Development and Scale Up”. He is executive editor and co-founder of Biotechnology Journal, and member of editorial boards from numerous journals in the area of biochemical engineering. He acts also a the vice president of research of the European Society of Biochemical Engineering Science.

Julian holds a degree in biochemical engineering and during his Master and PhD he started to develop and deploy model-based solutions for various biochemical processes. As post-doctoral researcher he founded and lead the Bioprocess Simulation and Control Team at the Technical University of Vienna and worked on lab digitalization and automation. After a short stay in an industrial research center, he joined DTU as an Assistant Professor where he now brings his developments from lab to pilot scale and from up- to downstream processing.

Prof Niclas Karlsson did his PhD in mucins and diseases in 1997 supervised by Prof. Gunnar Hansson and Dr Hasse Karlsson before joining in 1999 the Australian start-up company Proteome Systems Ltd working with Dr Nicolle Packer to develop current state-of-the-art N- and O-linked glycomics. In 2006 he worked with Bristol Myers Squibb to manage an Irish program to improve analysis during production of glycobiologicals. In 2009 returned back to academia as a principal investigator at Gothenburg University. Since 2021 he is appointed as full professor at Oslo Metropolitan University pursuing the role of O-linked glycans in dry eye disease and osteoarthritis. He has developed the global glycobioinformatic resources UniCarb working together with the Swiss Institute of Bioinformatics. He has published over 200 articles with an H index 57.

After a MSc in Biochemical Engineering and a PhD in protein analytics and machine learning, Marieke established a research group in 2020 at Delft University of Technology with a focus on applying advanced analytics to understand, develop, and control bioprocesses. The topics in her research group range from microbial fermentation to ATMP production, where synergy is found in the application of in-line analytics, development of technology to speed up data-driven modelling, and work towards data-driven control strategies.

Bas studied chemistry with specializations in bio-organic and biochemistry and obtained his Ph.D. in biochemistry from Nijmegen University. In 2001 he joined MSD, specializing in the field of protein formulation and protein analysis. He switched to the department of downstream processing in 2006 working on the development of protein purification processes. Since 2010, he is employed at Byondis as a principal scientist in downstream processing, working on process development of mAbs and ADCs, up to process validation and BLA writing. He is currently focusing on early-stage process development, including tech transfer to large-scale manufacturing.

Before joining Ring, Konstantin Konstantinov was responsible for the late-stage bioprocess and technology development at Sanofi’s Boston Hub, including all functions, from cell banking to fill/finish/lyophilization. Prior to Sanofi, Dr. Konstantinov worked for Bayer in Berkeley, California for 14 years, advancing to the position of Head of Process Sciences. He has published 60 peer-reviewed papers and has more than 15 patents and patent applications. During the last 23 years, Dr. Konstantinov has worked on the development and commercialization of various products, including monoclonal antibodies, blood factors and enzymes expressed in mammalian cells. Most recently, he has pioneered the development of an end-to-end integrated continuous biomanufacturing platform, which is becoming a strategic technological trend for the biomanufacturing industry worldwide. Dr. Konstantinov received his PhD in Biochemical Engineering from Osaka University, Japan, which was followed by a post-doctoral assignment at DuPont and the University of Delaware. He is a member of the board of directors for Repligen.

Emanuel received his PhD from the University of Vienna after conducting basic research in the lab of Jan-Michael Peters working on the mammalian cell cycle. This was a followed by a postdoc in the lab of Michael Hemann at the Massachusetts Institute of Technology establishing a high-throughput 3D cell culture system to perform CRISPR screens in spheroids. He used his skills gained during this endeavor by contributing to the establishment of The Antibody Lab, a start-up in the field of CHO cell line development using a novel approach for transgensis. Since 2019, Emanuel hast been a senior scientist in the upstream process development group at Ichnos Sciences focusing on media development and process optimization for bi- / multi-specific antibodies expressed in CHO.

Maximilian is responsible for Novasign's modeling projects in bioprocessing and helps to accelerate and better understand customers' bioprocesses by using advanced machine learning. He studied technical chemistry at TU Vienna and obtained his PhD from the University of Natural Resources and Applied Life Sciences. In his presentation, Maximilian will talk about predictive models and digital twins, and present showcases from upstream and downstream processing.

Christine Le Bec joined Sensorion Pharma, a company dedicated to the development of therapies for genetic forms hearing loss, in early 2020 as Head of CMC Gene Therapy. She is responsible of all CMC activities, including process and analytical development, CMC technology transfer to CMOs, manufacturing and supplying of phase I and II clinical trials. Before joining Sensorion Pharma, she worked for more than 20 years at Genethon in the field of Gene Therapy vectors (AAV, Lentivirus, Baculovirus) for rare diseases. She has a strong expertise in the development, qualification, validation of analytical methods for process and product characterization, release testing of gene therapy products and in stability studies. She has also a solid knowledge of International regulations and reviewing CMC documents for clinical trial applications.

Nico Lingg is senior scientist at the Austrian Centre of Industrial Biotechnology, specializing in downstream processes for biomacromolecules. He received his PhD degree in Biotechnology in 2014 from the University of Natural Resources and Life Sciences, Vienna. From 2011-2013 he conducted two years of PhD research at the Bioprocessing Technology Institute, Singapore. Here, he developed novel separation methods for monoclonal antibodies, based on controlled pH gradient elution in ion exchange chromatography. His current research focuses on platform processes for protein production, continuous bioprocessing and novel separation techniques for bionanoparticles, as well as fundamental research in chromatography. He is also actively involved in teaching the subjects of bioprocess engineering and downstream processing at his home university (BOKU) and at the Fachhochschule Campus Wien.

Dan Lundberg is an Associate Principal Scientist at AstraZeneca in Gothenburg, Sweden, where his key responsibilities include formulation screening and development and other CMC activities in pre-clinical and clinical development. He holds a Master of Science in Chemical Engineering and a Ph.D. in surface and colloid chemistry, both from Chalmers University of Technology in Gothenburg. Before joining AstraZeneca, Dan conducted postdoctoral research at Emory University, Atlanta, GA, University of Coimbra, Portugal, and Lund University, Sweden, and worked for research services provider CR Competence in Lund, Sweden. Dan has broad experience in applied physical and colloid chemistry, development of formulated products, and supporting pharmaceutical development projects.

Juergen is the co-founder of enGenes Biotech, leveraging his deep expertise in genetic and bioprocess engineering, as well as continuous bioproduction and plasmid DNA production. He previously worked as a Research Associate at the University of Natural Resources and Life Sciences (BOKU), Vienna, Austria. Before founding enGenes Biotech, Juergen held a Postdoctoral position at the Austrian Centre of Industrial Biotechnology (ACIB GmbH), where he contributed to the 'Microbial Cell Design' research initiative, focusing on sequencing and engineering various host strains for the production of recombinant proteins. In addition to his work on continuous bioproduction processes and plasmid DNA production, Juergen has authored numerous peer-reviewed scientific publications and book chapters. He has also received advanced training in Systems Biology and genome-scale stoichiometric modeling from the University of Iceland and in Microbial Genomics and Transcriptomics from the University of Bielefeld. He holds a PhD in Biotechnology from the University of Natural Resources and Life Sciences, Vienna, Austria.

Harris is Professor of Manufacturing Systems in the Department of Engineering at King’s College London and the founder of Centillion Technology Limited, a UK based biotech specialising in the rapid scaling and manufacture of RNA-based therapeutics and vaccines. He has a process engineering background with 27 years' experience in both industry and academia. In all his past and present roles, he is managing interdisciplinary projects that require integration and coordination. Harris is an expert in continuous RNA manufacturing. His work is focusing on addressing the challenges in the rapid design, development, and scalable manufacture of RNA and other nucleic acids and has pioneered the application of flow technologies in RNA manufacture, of various types. His research has attracted over £26m and he is currently leading a unique multi-disciplinary, multi-million pound programme comprising both industry and academia, building the Biofoundry-in-a-Box (BiaB). The BiaB is a unique portable, multi-purpose RNA microfactory designed for the rapid design and deployment of a range of therapeutics and vaccines, with Low and Middle Income Countries in mind. He has several patents in his name in the space of RNA manufacture and continuous bioprocessing. He is highly experienced in technology transfer to industry through a variety of commercial routes.

With a genuine interest in the design and application of label-free biophysical technologies sparked during her PhD at Lund University, Natalia has built a career advancing microcalorimetry, biosensors, and particle characterization tools for structural biology, drug discovery, and biologics development. Known for fostering strategic collaborations, she has held senior roles across academia and industry, including Pharmacia-Biovitrum, the Structural Genomics Consortium, CRO iNovacia, GE Healthcare, and Malvern Panalytical. Her recent focus is on fit-for-purpose analytics for nucleic acid–based drugs.

Damian Marshall is the Vice President of Analytical Development at Resolution Therapeutics, a UK biopharmaceutical company developing engineered macrophage therapies for end-stage liver disease. Prior to joining Resolution, Damian spent 2 years as Vice President of Bioprocess Development at Achilles Therapeutics and 8 years as Director of New Technologies at the Cell and Gene Therapy Catapult. In these roles he led multi-national programs working on bioprocess automation, PAT integration, and advanced product characterisation.

Dr Nicole Mather leads IBM’s Life Sciences consulting team across UKI and EMEA, which brings world-leading business, technology, and digital capabilities to innovative pharma and growing SMEs. Building on a vision to transform the future of health for patients, her teams combine a collaborative culture, innovative approaches, and technical depth to enable business transformation. IBM combines a trustworthy approach to AI and deep experience in data & hybrid cloud infrastructure to deliver change, safely at scale. Working with IBM Research enables cutting-edge technologies and methods to be incorporated into client solutions across UKI and EMEA. As Director of the Office for Life Sciences, Nicole shaped the UK ecosystem and health data environment and led the UK government on the development of the Life Sciences Industrial Strategy. Nicole is a Non-Executive Director of the Wellcome Sanger Centre and the Cell & Gene Therapy Catapult and holds a DPhil, MSc, and MA from the University of Oxford.

I graduated from Worcester State University with a double major in both Chemistry and Biology. I started my career working at Abbvie in Worcester, moving to Acceleron and now at Novartis. Over the past ten years, I have worked on multiple LC- and CE-based techniques for multiple therapeutic modalities including biologics, conjugates, and cell and gene therapies.

As Senior Director of External Manufacturing at AAVantgarde Bio, Mardon McFarlane brings two decades of biotech experience, supporting the progression of innovative therapies from development into the clinic. He has led CMC, process development, tech transfer, and manufacturing teams and initiatives across multiple modalities, including, mAbs, viral vectors, CAR-Ts, and CRISPR-based platforms, combining strategic insight and technical depth.

Jennifer McManus is currently the Head of the School of Physics at the University of Bristol. Her research focusses on phase transitions and assemblies of proteins. She is particularly interested in liquid-liquid phase separation and formulation of therapeutic proteins

Prof. Menegatti has earned his Ph.D. in Chemical Engineering at NC State University in 2013, with a project on affinity purification of protein therapeutics using peptide affinity ligands (advisor: Dr. Ruben Carbonell). After 2 years as a postdoctoral fellow working on drug delivery technology in the group directed by Dr. Samir Mitragotri at UCSB (now Harvard University), Dr. Menegatti rejoined the Department Chemical Engineering at NC State University as an assistant professor in 2015. Dr. Menegatti has made key contributions in bioseparations: he has introduced the new paradigm of “affinity flow-through chromatography” for continuous purification of therapeutic antibodies; he has invented and patented single-use adsorbents for plasma fractionation, and purification of CRISPR-Cas nucleases and other therapeutic proteins; he has developed novel, rapid at-line assays to support continuous bioprocessing; and designed novel biomaterials for drug delivery and tissue engineering. This intense research activity has translated into numerous impactful publications, patents, and invited lectures in universities and industries. Prof. Menegatti is highly recognized by the academic and the industrial communities alike, and has established a broad network of collaborations with distinguished scholars across three continents (US, Europe, and Australia). He also leads joint research projects with and consults for global companies including Merck & co., Genentech, Merck KGaa, CSL Behring, Millipore Sigma, KBI Biopharma, Johnson and Johnson, and Eastman Chemical Company. He was the key contributor to the $27M AIM-Bio research instituted funded in 2019 by the Novo Foundation (https://news.ncsu.edu/2019/08/future-of-biomanufacturing/). Dr. Menegatti has also established himself as a successful entrepreneur, pursuing the translation of his technology to broaden the access of patients of advanced biological therapies. His IP portfolio has been licensed to private companies - such as LigaTrap, for which he serves as main scientific advisor - and is now being converted into commercial products. Prof. Menegatti is actively engaged in a number of outreach activities in North Carolina: he co-chairs the Triangle Soft Matter Symposium, and collaborates with the NC Biotech Center, the NC Center of Innovation Network, and the UNC Institute for Convergent Science.

Dr. Anika Mijakovac is a young researcher working at Genos Glycoscience Laboratory since 2023. She studies the regulatory mechanisms of protein glycosylation, with a main focus on immunoglobulin G (IgG) antibody. Her main expertise encompasses molecular cloning methods, cell culture techniques, CRISPR/dCas9 technology, gene expression analyses and transposon systems. She is also extensively involved in teaching and writing. Anika received her PhD degree at the Faculty of Science, University of Zagreb in 2023. She conducted her PhD research in Professor Zoldoš Group for Epigenetics where she successfully developed IgG-secreting CRISPR/dCas9 cell lines and utilized them to study the genetic regulation of IgG glycosylation. She is currently expanding her research to other glycosylated proteins and is developing new cell lines to gain a deeper understanding of processes that regulate glycosylation.

Deana is a biotech entrepreneur and holds a PhD from ETH Zurich and a mini-MBA from Rudgers Business School with over a decade of leadership in regenerative medicine. As co-founder and CEO of MUVON, she is driving the clinical and commercial translation of cutting-edge muscle tissue-engineering therapies. Her seminal PhD research (2015) laid the scientific foundation for the clinical authorization of the MUVON`s tissue engineering platform technology, inspiring her to build an international consortium and secure a Horizon2020 grant to advance it from bench to bedside. Under her leadership, MUVON has grown into a high-performing team with experts from Novartis, Roche, Merck/MSD, IQVIA, Minaris, Takeda, ETH Zurich, and the University of Zurich. Recognized for her innovation and leadership, Deana received the Venture Leaders Award (2021), was named among InVivo’s Top 30 Rising Leaders (2022), featured for female achievement “Break the Bias” in Drug Discovery (2022) and won the Female Innovator Award (2023). Known for her strategic vision, integrity, and passion for improving human health, she continues to shape the future of regenerative medicine and women’s health through scientific excellence and entrepreneurial drive.

Thomas Müller-Späth, Dr. sc. ETH, Dipl.-Ing., is CEO and co-founder of ChromaCon AG, a YMC company. Thomas studied chemical engineering at the Technical University of Hamburg, Germany, and at UC Berkeley (USA). He obtained his PhD at ETH Zurich in the group of Prof. Morbidelli in 2008 on the topic of continuous chromatography. Thomas is inventor of several patents and has authored numerous scientific articles on continuous chromatography for biopharmaceuticals.

Dr. Mulukutla received his Ph.D. from the University of Minnesota’s Chemical Engineering program and joined Pfizer in 2012. At Pfizer, he is involved in developing cell culture processes for active portfolio projects and contriving newer technologies to improve cell culture process performance, specifically through optimization of cellular metabolism. Dr. Mulukutla’s Ph.D. research entailed identifying mechanisms that governed metabolic shifts to lactate consumption in the late stages of fed-batch culture by employing systems biology approaches. He developed a mechanistic kinetic model to demonstrate the presence of a multiplicity of steady states in glycolytic activity that could explain metabolic shifts in cell culture. For this work, Dr. Mulukutla received the award for best poster presentation at the Cell Culture Engineering XII conference in April 2010. Dr. Mulukutla and his research group at Pfizer has been developing novel technologies for enhancing the fed-batch processes of CHO cell lines used for therapeutic production. Dr. Mulukutla’s research team was the first to identify inhibitory metabolic byproducts produced in CHO fed-batch cultures, and devised strategies to alleviate the inhibition. His group has metabolically engineered CHO cells to reduce or eliminate production of these metabolic byproducts. The tyrosine prototrophs of CHO cells that his team engineered can synthesize tyrosine and proliferate in tyrosine-free environments. His recent work applied systems biology approaches to determine the underlying cause for the glycosylation dynamics observed in CHO fed-batch cultures. Dr. Mulukutla has co-authored 15 scientific articles, 2 patents and 3 patent applications, and is an active member of the cell bioprocessing community.

Darren Nesbeth is an Associate Professor of Engineering Biology in the Department of Biochemical Engineering at University College London (UCL) in the UK. Darren received a BSc in Molecular Biology from UCL in 1995 and a PhD in Molecular Cell Biology from Imperial College in 1999. Darren’s research interests are in the area of biological engineering of cells and viruses, using gene and protein design, in which areas he has over 100 publications. Fundamental contributions include: the manipulation of intracellular trafficking and synthetic gene networks to achieve bioprocess robustness and improved ability to engineer biological phenomena. Application domains of interest include: biological means to making cell and gene therapy more robust to industrial scaleup, and improving biosynthesis of vaccines, alternative proteins and cultivated meat.

Professor Neubauer is head of the Bioprocess Engineering Laboratory at TU Berlin which is leading in bioprocess scale-up and automated bioprocess development. He leads the KIWI-biolab which was selected as an International Future Laboratory in AI for bioprocess development. He is co-author in more than 300 publications and 20 patents and cofounder of the companies BioNukleo, Enpresso, and Cell-tainer. In 2023 he obtained the prestigious Thought Leader Award from Agilent.

Prof Nilsson has a PhD in Automatic Control from Lund University and is professor in Chemical Engineering with focus on advanced process engineering. He has worked in modelling of preparative chromatography for over 25 years. Recent research in focused on sustainable integrated continuous bioprocessing, advanced automation and model based control.

Emmanuel Nony, Ph.D. in pharmacology, has over 25 years of experience in the biopharmaceutical industry, focusing on biological characterization using mass spectrometry. Since 2025, he is Director of R&D External Innovations for Europe at Servier, leading collaborations to advance therapeutic solutions in cancer and neurological diseases. Previously, he directed Protein Sciences at Servier and led R&D activities at Stallergenes Greer, including the use of mass spectrometry for QC release testing of biologics. Emmanuel has contributed to 10 successful marketing authorizations of biologics and holds several patents in this field.

Rui Oliveira is a Full Professor of Chemical and Biological Engineering at NOVA University Lisbon, Portugal, and heads the Systems Biology and Engineering Lab at NOVA FCT. His research focuses on hybrid modelling, metabolic modelling, machine learning, and bioprocess optimization and control within the frame of Industry 4.0. He has been deeply involved in digital innovation in the biotechnological sector, bridging advanced computational methods with real-world industrial applications.

Margaux Ouvry holds a Biotechnology Engineering degree from ENSTBB and joined Sanofi in 2019. She initially worked in production support, managing deviations, CAPAs, change controls, and technology transfers as a receiving unit specialist. She then moved to MSAT focusing on DSP technology transfers before joining the CMC Purification Process Development department (PPD) in late 2022.

Within CMC, the PPD team operates at the interface between R&D and commercial manufacturing. The team's mission is to establish scalable manufacturing processes for monoclonal antibodies intended for clinical trial production.

Margaux works on mAbs in Phase 1 and Phase 3 clinical trials, while also contributing to platform innovation through the evaluation and implementation of new purification technologies to enhance process efficiency and robustness.

Bilal is an Associate Senior Scientist at the Cell & Gene Therapy Catapult, where he specialises in the downstream processing of viral vector based gene therapy products. Bilal's current line of work includes the development of a semi-continuous platform for AAV viral vectors, with focus on capture chromatography optimisation using the BioSMB. Bilal's previous experience includes working for Pall Life Sciences (currently known Cytiva), where he worked across the R&D department.

Chiara Pacini is a Senior Field Application Specialist (FAS) at Cytiva, based in Milan. She supports customers across Southern Europe, Eastern Europe, and the Middle East. Chiara holds a degree in Industrial Biotechnology from Bicocca University, where her research focused on developing nanoparticles as drug carriers for oncology therapies. She joined Cytiva in 2023 as a Field Application Specialist specializing in viral and non-viral vectors, including mRNA-LNPs, exosomes, and oligonucleotides. In her role, Chiara partners with biopharmaceutical companies to optimize purification strategies for viral vectors, offering scientific guidance on chromatography, filtration technologies, and process intensification. contributing to improved yield, purity, and robustness of manufacturing processes in regulated environments. Chiara is actively involved in implementing scalable and innovative solutions, with a focus on scale-up of continuous processing end-to-end solutions.

George obtained his MEng in Chemical Engineering from the University of Birmingham, UK, and has eight years’ experience as a biochemical engineer specialising in the purification of viral vectors for vaccines and Cell and Gene Therapy (C>) applications. He began his career in monoclonal antibody manufacturing at Pfizer (Ireland) before joining the Process Science and Innovation (PSI) team at the C> CDMO Oxford Biomedica (OXB). At OXB, his work focused on developing innovative purification strategies for lentiviral vector (LV) bioprocesses. Among his notable contributions were the development of OXB’s next-generation LV manufacturing platform, Process C, and process development for the Oxford/AstraZeneca COVID-19 vaccine, formerly known as ChAdOx-1. George’s research interests centre on chromatographic separation of gene delivery vectors. In 2021, he embarked on a PhD at University College London in collaboration with OXB, under the supervision of Prof. Daniel Bracewell. His project advanced understanding of LV adsorption during anion-exchange chromatography, identifying key viral and adsorbent structural factors governing binding and product loss. This work led to a collaboration with Sartorius to develop their next-generation chromatography material (Sartobind® Convec D), which achieved a 3.5-fold improvement in LV manufacturing yields. George also has a strong interest in digital bioprocessing, having developed mechanistic chromatography models to enable in silico development of LV chromatography processes.

Jan Panteli is an upstream process development lead at Ultragenyx Pharmaceutical with 5 years’ experience in developing AAV gene therapies, three AAV-technology patents, and multiple peer-reviewed publications. Prior to joining Ultragenyx, he earned his BS in chemical engineering from SUNY Buffalo (2009) and PhD from UMass Amherst (2015) where he focused on diagnostic and therapeutic approaches for cancer by genetically modifying microbes to overcome transport limitations phenomena in solid tumors.

Innovative Data Scientist with 6 years of experience in pharma R&D, driving digital transformation through machine learning, bioinformatics, and multimodal data integration. Experienced in translating complex biological data into actionable insights and developing ML-based decision-making tools that enhance R&D processes. Passionate about enabling value-based therapeutic innovation by bridging science, data, and business strategy.

Cristina Peixoto graduated in Applied Chemistry (Branch Biotechnology) New University of Lisbon and she holds a PhD in Engineering Sciences from Instituto de Tecnologia Quimica Biológica (ITQB) from New University of Lisbon. Working in Animal Cell Technology field since 1996, her PhD contributed to the establishment of several scalable purification processes for complex biopharmaceuticals, mainly virus and virus like particles for vaccine and gene therapy. Cristina coordinated several research contract projects with Industrial partners, some of the processes developed are nowadays in GMP for phase I and II and she published over 60 manuscripts in refereed international journals.

Mario Pereira has a diverse work experience history. Mario is currently the Director of Technology and Business Development at ATUM since March 2023. Prior to this, they worked at Horizon Discovery from 2016 to 2023 in various roles including Strategic Account Manager, Field Application Scientist, and Senior Scientist. At Horizon Discovery, they were responsible for commercial activities, technical input in pre and post-sales, and development of the CLD platform. Mario also worked as a Principal Scientist at FUJIFILM Diosynth Biotechnologies from 2015 to 2016, focusing on developing recombinant CHO cell lines. Mario Pereira completed their Biotechnology PhD at the University of Manchester from 2011 to 2015, where their research focused on genomic environment for recombinant gene expression. Mario has also been involved in various outreach and community activities, including roles at PARSUK and Oxbridge Biotech Roundtable. Mario Pereira began their education in 2005 at the Universidade de Coimbra, where they obtained a Bachelor of Science degree in Biochemistry in 2008. Following this, they pursued a Master of Science degree in Biochemistry from the same institution, completing their studies in 2010. Mario then continued their academic journey at The University of Manchester, where they enrolled in a Doctor of Philosophy program in Biotechnology. Mario successfully completed their PhD in 2015, thus furthering their expertise in the field.

Patricia Pereira Aguilar is a Senior Scientist at the Austrian Centre of Industrial Biotechnology (acib, GmbH) and integrated in the Institute of Bioprocess Science and Engineering (IBSE) at the BOKU University, Vienna, Austria. In 2020, she completed her Ph.D. degree in “Biomolecular Technology of Proteins” (BioTop) at BOKU, under the supervision of Professor Alois Jungbauer. After that she started working as a Postdoctoral Researcher at acib and since January 2024 as a Senior Scientist and Research Group Lead. Her research focus on the development of downstream processes and analytical tools for enveloped bionanoparticles for vaccine and gene therapy applications, such as virus-like particles, viruses and extracellular vesicles. Her expertise includes chromatography, filtration and ultracentrifugation techniques and biochemical and biophysical assays for bionanoparticle/protein/nucleic acid quantification and characterization. Within her work as Scientist/Senior Scientist, she has contributed to grant/project writing, application and acquisition, project lead, publication writing and reviewing, participation in international conferences, and supervision and guidance of PhD/Master students and technicians.

Andreja Pirnat is an Expert in Science & Technology with experience in bioprocess development, currently based in Novartis Slovenia. Her work focuses on advancing downstream processing strategies to meet the challenges posed by high-titer upstream processes. With a strong background in biotechnology and process engineering, Andreja has led and contributed to numerous projects aimed at optimizing purification platforms, improving scalability, and enhancing process robustness. At this year’s Bioprocessing Conference, Andreja will present innovative downstream solutions tailored for high-titer bioprocesses, addressing key bottlenecks and offering practical insights into achieving efficiency and product quality in large-scale manufacturing. Her talk will highlight integrated approaches, including novel chromatography strategies, filtration technologies, and process intensification techniques.

Bio

Maria del Carme Pons Royo is a bioprocess engineer with experience in development and optimization of biotechnological products. She completed her bachelor's degree in biotechnology from Universitat Autonoma de Barcelona, followed by a master's degree in Life Science and Technology from TU Delft. Recently, she successfully defended her PhD thesis at BOKU, titled "Millifluidic devices to accelerate process development with a primary focus on protein precipitation and filtration." Currently, she is employed as a postdoctoral researcher at MIT, where she continues her research on the development and optimization of innovative bioprocesses utilizing cutting-edge prototyping tools.

After studying at ENS Cachan (now Paris-Saclay), Arnaud Poterszman completed his PhD from Strasbourg University and joint the CNRS one year later. He holds a Research Director position and performs his studies in the Department of Integrated Structural Biology at IGBMC, Illkirch France. He has a dual expertise in Structural and Molecular biology with insights on expression technologies and sample preparation. His research is focused on eukaryotic multi-protein complexes involved in transcription regulation and DNA repair by nucleotide excision, particularly, the transcription/DNA repair factor TFIIH and its partners (Orchid 0000-0002-6702-5777)

Geoffrey Pressac is Senior Expert SDS Chromatography at Sartorius where he has held various positions since 2016. In those years, he has supported customers from PD to manufacturing on their entire downstream, with a focus on chromatography and process intensification since 2020. Over the years, he gained experience in purifying both proteins and large molecules like exosomes, pDNA, mRNA and various viruses. Before Sartorius, he worked for three years at Texcell, a company providing viral safety testing and virus clearance studies in France. Geoffrey holds a master’s degree in Biotechnology since he graduated from ESIL in 2012.

Nic Preyat holds a PhD in Immunobiology. His academic research focused on understanding cell and molecular mechanisms controlling the immune response, and cell death pathways. During his post-doctoral studies, Nic Preyat investigated the possible implementation of new therapeutic strategies to fight cancer. He also developed tools to characterize biomarkers for inflammatory diseases. Nic had several scientific and leadership positions within two global CDMOs, Masthercell and Catalent, developing and manufacturing cell and gene therapy products. Nic Preyat had contributed to the development of various products ranging from viral vectors to CART from early development to transition for commercial manufacturing. At UCB Nic Preyat is now leading a team responsible for the development and manufacturing of rAAV with the ultimate goal to treat patients with neurodegenerative disorders. Through the various positions he assumed, Nic Preyat has acquired a strong expertise in cell culture, CMC development, technology transfer, good manufacturing practices and project management.

Eva Price is a PhD researcher in Biochemical Engineering at University College London, working in collaboration with Oxford Biomedica in the cell and gene therapy domain. With a background in Genetics and Cell Biology (BSc, Dublin City University) and Data Analytics for Precision Medicine (MSc, University College Dublin), she specialises in applying computational biology, bioinformatics and machine learning to complex biological questions. Her work integrates genomics, transcriptomics, single-cell transcriptomics, epigenomics, proteomics and metabolomics to inform cell line engineering. Skilled in cloud computing and workflow automation with Nextflow, she has published on robust data collection and cleaning methods and has been recognised with AWS scholarships for her expertise in cloud-based bioinformatics. Her current research applies data-driven approaches to elucidate the molecular landscape of HEK293 cells, with the goal of accelerating innovation in advanced therapies.

Dr. Jack Prior leads MSAT Process Monitoring & Data Science/AI Strategy at Sanofi, where he spearheads global initiatives in process monitoring and AI-driven yield improvement for biologics manufacturing. Previously as Head of MSAT Digital, he led teams working to develop global process data analytics systems and to digitize laboratory operations for Industrial Affairs Specialty Care drug substance and drug product manufacturing. Jack’s career at Sanofi-Genzyme spans nearly 3 decades, where he has led manufacturing science organizations supporting process characterization, modeling, technology transfer, and manufacturing operations for critical therapies treating rare genetic disorders. Throughout his career, he has focused on integrating process modeling and advanced analytics with manufacturing science to enhance biologics production across US and European operations. Dr. Prior holds a Doctor of Science in Chemical Engineering from MIT and a Bachelor of Science in Chemical Engineering from the University of Connecticut.

Jukka Rantanen is professor and head of department at the Department of Pharmacy (University of Copenhagen). He has a long experience in public-private co-operation in Europe, the US and Asia, where he has been involved in several large industry co-operation project with 20+ international companies within fine chemical industries. Jukka is a member of the Process Analytical Technology (PAT) Working Party of the European Pharmacopoeia Commission. He is currently a chairman of the Steering Committee of the EUFEPS QbD and PAT Sciences Network (EUFEPS, European Federation for Pharmaceutical Sciences). Jukka Rantanen has supervised 40+ PhD students. He has 350+ publications in scientific peer-reviewed journals and he is an editorial board member of several leading scientific journals within pharmaceutical sciences.

Ian joined the MHRA as a GMP inspector in 2001, before this he was an inspector with the Veterinary Medicines Directorate and before that he helped create a startup biopharmaceutical firm during which time it was authorised by US FDA and MHRA’s predecessor, the MCA. In 2004, Ian became a manager responsible for the London based team of GMP inspectors, he was promoted to Expert GMP Inspector in 2006 and Unit Manager Inspectorate Strategy and Innovation in 2014 managing a team of Expert GXP Inspectors. Between 2008 and 2015, Ian was MHRA’s representative on the EMA’s GMDP Inspectors Working Group and also chaired the EMA/HMA Joint Audit Programme. Ian was part of the team that created MHRA’s Innovation Office in 2013 to provide regulatory advice to organisations developing innovative processes or novel manufacturing processes. Ian led MHRA’s work in developing the new regulatory framework for decentralised manufacture. Although he retired from MHRA in March 2023 he has since rejoined MHRA on a part-time basis to help complete the development of this new regulatory framework. On January 23rd 2025 the legislation (SI 2025 87) was signed into UK law and guidance documents were published on 10 June ahead of the legislation coming into effect 23rd July 2025.

Dennis Rhodes is an Associate Director of Analytical Development and Quality Control at Ionis Pharmaceuticals, bringing more than 15 years of expertise in the field. His work focuses on the characterization and quality oversight of raw and starting materials for oligonucleotide therapeutics, with a particular specialization in nucleoside phosphoramidites. He is passionate about ensuring the highest standards of quality in therapeutic development and supporting innovation in the oligo space.

Dr Ridhurkar is CEO of RidNova Pharmaceuticals and a Biopharmaceutical Subject Matter Expert based in Barcelona, Spain. He boasts over 19 years of invaluable scientific leadership and management expertise in the complex formulation development and manufacturing of small and biological compounds. Renowned for his proficiency in steering projects encompassing advanced and targeted drug delivery for the Biosimilar, Protein and Peptides, Proprietary and Generic drugs, including 505b2, Hybrid, Complex, Speciality, and Branded formulations, he has significantly impacted Pharma-Biotech companies worldwide.

Dr. Roberts is a Professor in the Department of Chemical and Biomolecular Engineering at the University of Delaware (UD), and the Associate Institute Director for the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). He also serves as the Director of the Biomolecular Interaction Technologies Center (BITC) and the Director of the Center for Biomanufacturing Science and Technology (CBST) at UD. He received a Bachelors of Chemical Engineering degree from UD, and a Ph.D. in Chemical Engineering from Princeton University. Prior to joining UD, he worked at Pfizer as a formulation scientist for protein and small-molecule based therapeutics. The research focus of the Roberts laboratory is on experimental and theoretical fundamentals and applications of protein physical and chemical stability to address questions of biopharmaceutical product design, stability, and manufacturing.

Cecília Roque is a Full Professor in Bioengineering and head of the Biomolecular Engineering Lab at the School of Science and Technology, NOVA University of Lisbon. She is UCIBIO Director since February 2023. Cecilia holds a degree in Chemical Engineering (Major in Biotechnology) and a PhD in Biotechnology from Instituto Superior Técnico. Cecília has been a Visiting Scholar at the University of Cambridge and at the Catholic University of America, a Post-doctoral researcher at the Institute of Biotechnology (University of Cambridge) and at INESC-MN (Lisbon, Portugal), and a Visiting Professor at the University of Cambridge, University of Nantes, University of São Paulo, City University of New York and KTH Royal Institute of Technology in Stockholm. She is active in several national (Biotechnology Portuguese Society and Biophysics Portuguese Society) international scientific societies (European Federation of Biotechnology and International Society for Molecular Recognition). Her research focus on biomimetics merging chemistry, biotechnology and engineering, and her work has been merited with several national and international distinctions. She has been awarded Starting and Proof-of-concept grants from the European Research Council (2014, 2022, 2024), and is currently leading a FET-OPEN project in the field of bioprocessing. https://biomolecular-engineering-lab.pt/

Avraham Rosenberg earned his master’s degree in biotechnology from Johns Hopkins University. He is currently a Principal Scientist at Regeneron Pharmaceuticals, Inc. and has spent the last 15 years pushing biotherapeutic drug candidates through the pipeline, while developing new mass spectrometry-based techniques. Prior to joining Regeneron, he spent 4 years in academic research: 1 year at Johns Hopkins University in Dr. Jenny Van Eyk’s proteomics laboratory and 3 years at the National Institutes of Health in Dr. Irving Wainer and Dr. Ruin Moaddel’s laboratory of clinical investigation.

Florence holds a PhD in Molecular and Cellular Biology from Strasbourg University. She gained considerable experience in product development and regulatory affairs, bringing many of the early cell and gene therapies from the bench to the clinic in the early 2000s, and to approval such as Glybera (first gene therapy in the EU) in 2012. She supported the development of a number of AAV-based gene therapy vectors for various disease areas. From 2014 to 2021 she was Director Global Regulatory Affairs CMC Cell and Gene Therapies, where she worked on the global approval of Kymriah (first CAR T product), Luxturna and Zolgensma. She has worked as regulatory affairs and development expert for several start-ups and venture funds before joining Hookipa Pharma in 2023 to support the late stage development of their arenaviral vectors in various cancer indications.

I am a Scientist at the Cell Line Development and Molecular Virology Lab, where I have been working since 2023. My research focuses on developing producer cell lines for manufacturing viral and virus-derived vectors used in gene therapy, with an emphasis on engineered virus-like particles. My special interests include using genome editing as a therapeutic tool for Cystic Fibrosis and other rare diseases. I hold a BSc and an MSc in Biomedical Sciences from the University of Algarve, Faro, Portugal (2014), and a PhD in Biology from the University of Lisbon, Lisbon, Portugal (2022). My PhD work was conducted in collaboration with Dr. Farinhas’ Lab (BioISI, FCUL) and University College Cork, Cork, Ireland, where I spent two years working in Dr. Harrison’s Lab. My previous professional experience includes roles as a Postdoctoral Researcher at BioISI – BioSystems and Integrative Sciences Institute, Lisbon, Portugal (2022-2023), and at University College Cork, Cork, Ireland (2021-2022). I received the 2023 Gerd Döring Award for outstanding young European scientists, awarded by the European Cystic Fibrosis Society, and the 2022 Innovator of the Year (Life Sciences) Research Award, presented by University College Cork.

Isabelle Savoy is a Senior Manager in Downstream Process Development at Novartis Pharma, within the Technical Research and Development department. With over 15 years of experience in the biopharmaceutical industry, she leads a team focused on the development and optimization of purification processes for a wide range of therapeutic modalities, including monoclonal antibodies, Fabs, Fc-fusion proteins, bispecific antibodies, and other biologics. Isabelle has developed purification processes for more than 20+ molecules and played a pivotal role in scale-up, technology transfer, and manufacturing support for toxicological and early-phase clinical production. She holds a degree in Biochemical Engineering from the University of Applied Sciences in Sion, Switzerland.

Matthias Schad, Senior Scientist in the Viral Therapeutics Center at Boehringer Ingelheim in Biberach, is responsible for the CMC Drug Product Development in one of the oncolytic virus projects currently in clinics. Before this position, Matthias gained around 10 years experience in drug substance process transfer and scale-up in various protein-based modalities.

Theresa SCHARL is Senior Scientist at the Institute of Statistics at BOKU University, Vienna. Previously she worked as a researcher in the Austrian Center of Industrial Biotechnology (acib). Her research interests include statistical computing, cluster analysis, classification, machine learning and statistical applications in life sciences. She has experience in the analysis of high-dimensional data of bioprocesses such as (time-course) gene expression data from microarrays or RNA sequencing. A second line of research is on the (real-time) monitoring and control of upstream and downstream processes.

David Scheich is a third year PhD student at BOKU University in Vienna in the working group of Nico Lingg. His current focus is on the purification and characterization of secretory immunoglobulin A using affinity chromatography, which includes the development of a novel resin to improve the capture process.

Lina Schulte is a Scientist at StemVAC GmbH, the German subsidiary of Calidi Biotherapeutics. She received her master’s degree in Bioengineering in 2022. StemVAC focuses on process and analytical development of oncolytic virus therapy. At StemVAC, Lina Schulte is responsible for upstream development. She performs small scale process optimizations of cell culture and virus production, as well as the scale-up to a bioreactor.

With a background in biology, I began my scientific career at Vanderbilt University, where I focused on proteomics and studied antibody responses to flu vaccines. I later joined the Broad Institute of MIT and Harvard, developing high-throughput assays to support small molecule hit validation. Currently, I’m a Senior Scientist at the Novartis Institutes for BioMedical Research, where I specialize in mass spectrometry-based characterization of therapeutic modalities, including antibodies, lentiviruses, and adeno associated viruses, across multiple pipelines.

Andrew has over 30 years’ design and operational experience in the biopharmaceutical industry, with direct responsibility for manufacturing, logistics, maintenance and capital programme management. He has developed Biopharm Services into a leading provider of bioprocess modelling and knowledge management tools that support bioprocess innovation. The focus of his work is in the understanding the impact of innovative technologies on biomanufacturing with focus on single use systems and continuous processing. Prior to Biopharm Services, Andrew was Director of Engineering and Logistics at Lonza Biologics and holds an MSc in Biochemical Engineering from UCL. He was a finalist in “The Manufacturing Processing Thought Leader of the Decade” category at the 2012 BioProcess International Awards and in 2014 was appointed a Fellow of the Royal Academy of Engineering in the UK.

Dr. Michael Sokolov is co-founder and COO of DataHow AG, a spin-off company from ETH Zurich specialized on process data analytics and modeling with a particular focus on the biopharmaceutical and chemical domains. He also holds a lecturer position for statistics for chemical engineers at ETH.

Mattia Sponchioni received his Master of Science in Chemical Engineering in 2015 with a grade of 110/110 cum laude and his PhD cum laude in Industrial Chemistry and Chemical Engineering in 2018, both at Politecnico di Milano. After his PhD, Mattia spent one year as a post-doc at ETH Zürich in 2019, working on the development of continuous countercurrent chromatographic processes for the purification of biopharmaceuticals, from therapeutic proteins to oligonucleotides. From 2020 to the present he is an assistant professor at the Department of Chemistry, Materials and Chemical Engineering “G. Natta” at Politecnico di Milano. Here, Mattia Sponchioni is leading the group of biomanufacturing, active in the development of continuous perfusion processes for the production of mRNA and bioplastics via fermentation and in the conversion of the traditional single-column batch chromatographic purifications into continuous countercurrent processes based on two twin columns. The vision of the group, inspired by the principles of Industry 4.0, is towards process intensification, to be achieved through both continuous processes and integrated manufacturing, as a way not only to increase productivity but also the sustainability of biomanufacturing, by reducing the wastes of buffers and feedstocks in the direction of a reduced environmental footprint.

Artur Stanczak is a Process Chromatography Application Specialist at Bio-Rad Laboratories. He received his Master of Science in Biotechnology from the University of Maria Skłodowska-Curie in Lublin. Artur has more than 13 years of experience in the biotechnology and biopharma industry, specializing in downstream processing of therapeutics. Experienced in process development, characterisation, scale-up and validation of biologics. Artur supports method development, downstream purification applications and the Bio-Rad chromatography resins portfolio as well as managing the process chromatography application laboratory located in Munich, Germany.

Sam Stricker is a PhD student in Chemical Engineering at Imperial College London, where he investigates the integration of artificial intelligence and digital twins to enhance manufacturing and laboratory operations. He earned a Master of Science in Chemistry from ETH Zurich, focusing on electrochemistry for energy storage and conversion, machine learning, and modeling. His master’s thesis, supervised by Prof. Dr. G. G. Gosálbez and Dr. A. Butté, addressed model-based optimal design of experiments for bioprocesses using hybrid models. Professionally, Sam worked as an Algorithm Research Associate at DataHow AG, advancing methods for uncertainty estimation and experimental optimization in bioprocess development.

University Professor at the Department of Biotechnology (BOKU), Head of the Institute of Bioprocess Science and Engineering, Head of working group fermentation technology and principal investigator in the Austrian Center of Industrial Biotechnology (ACIB). The working group has established an integrated systems approach for bioprocess development and is focused on the implementation of PAT and QbD concepts in bioprocessing and rational host cell design. CHO, E. coli, insect cells and vero cell lines are used as expression systems for production of a representative set of biopharmaceuticals (mABs, Fabs, scFvs, VLPs, viruses, DNA.

Yue Su is a Senior Scientist at Regeneron, where she contributes to the characterization of biotherapeutics, including monoclonal antibodies, bispecifics, RNA biotherapeutics, and other modalities to support drug development. Since joining Regeneron in 2023, Yue has applied her experience from her postdoctoral research in Dr. Shenglong Zhang's lab, where she worked on mass spectrometry-based direct RNA sequencing and modification studies. She has a keen interest in the accurate identification and quantification of RNA modifications, and she is dedicated to advancing the understanding and development of therapeutic solutions.

Dr Sara ten Have is a proteomic scientist from New Zealand, based in Scotland. She specialises in Mass Spectrometry with a focus on clinical peptide analysis for discovery, pathology and drug interaction elucidation. She has a particular passion for green chemistry, and it's applications for improving human and planetary health.

Thomas Tröbs is an experienced Diplom-Ingenieur (University of Applied Sciences Degree) in Pharmaceutical Biotechnology with expertise in USP Project and Platform Development. He has been working at Roche Diagnostics GmbH in Penzberg since December 2006 as an Engineer Development Fermentation , where he focuses on the development of CHO cell culture processes for monoclonal antibody production and supports local and global process transfers. Within Roche, he has also served as an Expert for Cell Culture Media since 2015 , developing media and managing troubleshooting and optimization. Since 2020, he has been a coordinator for Roche Cell Culture Media and Processes, responsible for transparency, accessibility, transferability and changes. His professional experience includes a job rotation as a Process Engineer in clinical GMP Production at Roche from June to December 2019 and earlier roles at Boehringer Ingelheim Pharma GmbH & Co. KG as a Diploma candidate and intern in biopharmaceutical manufacturing and GMP. He also worked as a student assistant at the Leibnitz Institute for Natural Product Research and Infection Biology. His education, a Diplom-Ingenieur in Pharmaceutical Biotechnology, was completed at Fachhochschule Jena between 2001 and 2006. He is currently based in Jena and speaks German (native language) and is fluent in written and spoken English.

Dr. Shahid Uddin is currently Director of Drug Product, Formulation & Stability within the CMC department at Immunocore. His team is responsible for bringing research candidates into clinic and commercialization. Technology is focused around developing ImmTAC as therapeutic agents for different disease models. Prior to this he held the position of Head of Formulation at MedImmune (AstraZeneca) where he supported the biologics portfolio covering Monoclonal antibodies, Peptides, bispecifics, and other proteins. He has extensive experience in pre-formulation/formulation, forced degradation, delivery of biologics both for early and late-stage programs.

Dr. Igor Vassilev is the Manager of the Application Laboratory at the Eppendorf Bioprocess Center in Jülich, Germany. He holds a Bachelor’s and Master’s degree in Chemical Biology from the Technical University of Dortmund, Germany, and earned his Ph.D. from the University of Queensland, Australia, where he worked on microbial electrosynthesis. His innovative research was recognized with the Discovery Award for Best Scientific Paper in 2018 and the Innovation Award for Best Technological Advancement in 2019. Igor has gained international experience working in leading laboratories at Saarland University (Germany), Tampere University (Finland), and Wageningen University (Netherlands). In early 2023, he joined Eppendorf as Application Laboratory Manager, where he continues to drive the development of innovative bioprocess solutions.

Salvador Ventura, PhD is Professor of Biochemistry and Molecular Biology at the Universitat Autònoma de Barcelona (UAB) and Scientific Director of the Institut d’Investigació i Innovació Parc Taulí (I3PT-CERCA). He leads the Protein Folding and Conformational Diseases Laboratory, where his research explores the molecular mechanisms of protein folding, misfolding, and aggregation, with applications in neurodegeneration, nanomedicine, and biotherapeutic design. He obtained his PhD in Biology from UAB and pursued postdoctoral research at the European Molecular Biology Laboratory (EMBL, Heidelberg), with subsequent research stays at Harvard Medical School (USA) and Karolinska Institutet (Sweden). Since returning to UAB as a Ramón y Cajal Investigator, he has established a multidisciplinary program combining computational biology, structural biochemistry, cellular and animal models, and translational approaches. Ventura is internationally recognized for developing widely used computational tools to predict and redesign protein aggregation, such as Aggrescan and Aggrescan3D. He has published more than 300 research articles, authored book chapters, and is co-inventor on 18 patents. His group has contributed to the design of novel protein-based nanostructures with therapeutic potential and has engaged in collaborations with pharmaceutical and biotechnology companies. He is cofounder of Eureka NanoBioEngineering, a spin-off dedicated to nanobiotechnology solutions, and a member of the Academia Europaea. His contributions have been recognized with several awards, including the Bruker “Manuel Rico” Prize, the Narcís Monturiol Medal, and three ICREA Acadèmia distinctions.

Thomas Villiger heads the Bioprocess Technology Laboratory at the University of Applied Sciences Northwestern Switzerland (FHNW). With over a decade of industrial experience, his research focuses on novel biopharmaceutical modalities and optimising their manufacturing processes by leveraging process intensifications, process analytical technologies, and mathematical modelling. He holds a Master's and PhD in Chemical and Bioengineering from ETH Zurich.

Dr. Joaquim Vives, a biochemist with a PhD in Biochemistry, has extensive experience in R&D, focusing on cellular processes for therapeutic and diagnostic applications. He leads a research group at Banc de Sang i Teixits (Barcelona, Spain), developing Advanced Therapy Medicinal Products, and teaches at Universitat Autònoma de Barcelona. He has published 70+ articles, holds 3 patents, supervised 8 PhDs, and has served in leadership roles in scientific societies.

Dr. Fabian Vogt studied Biology at the University of Tuebingen, where he developed a strong foundation in molecular and cellular biology. He subsequently completed his Ph.D. in Oncology, focusing on the development of bispecific antibody constructs. One of these constructs has successfully progressed into early clinical trials. Following his doctoral studies, he pursued a postdoctoral position, further deepening his expertise in antibody engineering and oncology. He then transitioned to Sartorius Cellca, where he managed cell line development (CLD) projects with a particular emphasis on downstream processing (DSP) and analytical development. For the past three years, Dr. Vogt has served as Head of Laboratory at Boehringer Ingelheim in the Downstream Development department. In this role, he leads the development of state-of-the-art biologics projects across both early and late stages and driving innovation in DSP strategies.

Bjørn Voldborg has more than 20 years of experience working with recombinant protein expression from both academic and industrial settings. Bjørn was team leader in the biotech company Pharmexa A/S, responsible for molecular cloning and expression of protein-based drug candidates. From this, he went to the NNF Center for Protein Research at the University of Copenhagen as Head of the Protein Production Unit, and, since 2012, Bjørn has been heading the CHO Cell Line Engineering project dedicated to the engineering of improved protein production cell factories, and since 2021 he has been heading the Cell Line and Protein Production in the National Biologics Facility at the Technical University of Denmark.

Jason Vorhees is the Head of Manufacturing at Genentech’s Cell Therapy site in Hillsboro, Oregon, bringing over 25 years of extensive experience in Biopharmaceutical manufacturing. His career has spanned key leadership roles in Process Development, Manufacturing Science and Technology (MSAT), and Project Management at major industry organizations including Roche/Genentech, Amgen, and Baxter BioScience. Mr. Vorhees is recognized for his commitment to operational excellence, driven by a deep passion for simplification and engineering robust solutions to error-proof challenging manufacturing operations.

Ian Walsh is part of the Analytical Science and Technologies division and the leader of the GlycanAnalytics group. Ian has published 45 peer-reviewed articles in the past 15 years in the glycobiology and computational biology fields. He is developing wet lab and computational methods for more efficient and accurate carbohydrates analysis using state-of-art instrumentation like liquid chromatography, mass spectrometry, capillary electrophoresis, ion mobility and combinations thereof. He is also focused on the creation of novel adaptive machine learning and other computational modelling tools to: help understand bioprocessing data, develop real-time models of the bioprocess to predict the quality of cell cultured therapeutics and control the quality of the same therapeutics. Ian has skills in computer science, machine learning, statistics, mathematics, software engineering as well as biology.

Paul Wassmann, Ph.D., Senior Principal Scientist, NIBR Biologics Center (NBC), Novartis Pharma AG, Switzerland Analytical technology and strategy lead for NBEs at the Characterization/ Formulation/ Bioinformatics unit (CFB). This role includes evaluation and coordination of implementation of appropriate innovative and strategic concepts in analytical space for challenging and completely new Biologics modalities with main focus on liabilities evaluation of Biologics molecules and their developability assessment. Prior industry experience includes Project management for Biosimilar projects at Solvias AG, Switzerland, and Scientific role in Antibody Engineering and Analytics departments at Glenmark SA, Switzerland. Holds a doctorate in Structural Biology from Biozentrum Basel, Switzerland.

I am Associate Director, CMC at Complement Therapeutics in London, where I lead CDMO-driven CMC activities to support the development of a gene therapy for Geographic Atrophy. With nearly 20 years of experience, I’ve held roles at Biogen, Nightstar Therapeutics, and the Cell & Gene Therapy Catapult. My background includes Analytical Development and managing CDMO-led product development from early-stage through to GMP manufacturing for clinical trials, with a strong focus on gene therapy.

Birgit Wiltschi received a PhD in Biochemistry from Graz University of Technology in Austria. She continued her scientific work as a postdoc at the Max Planck Institute of Biochemistry in Martinsried, Germany and afterwards was a group leader at the Albert-Ludwigs University of Freiburg, Germany. After her return to Austria in 2011, she became the head of the Synthetic Biology Group at the Austrian Centre of Industrial Biotechnology. In 2020, she joined the Institute of Bioprocess Science and Engineering at BOKU University in Vienna as a principal investigator and a faculty member of the BioProEng doctoral school. Her research focuses on the engineering of proteins and peptides using unnatural amino acids, for instance to introduce site-selective bio-orthogonal protein modifications.

Joy Yoon is an Associate Scientist in the Analytical Chemistry group at Regeneron, specializing in characterizing and validating therapeutic proteins during pre-clinical drug development using advanced LC-MS methods. Her expertise encompasses post-translational modifications (PTMs), disulfides, N-glycans, and hydrogen-deuterium (HD) exchange for protein structure and antibody-antigen binding analysis. Joy has developed a holistic approach to protein characterization, enabling the creation of automated experimental and analytical frameworks for high-throughput PTM screening. Her contributions enhance the efficiency and accuracy of therapeutic product analysis, supporting critical drug development processes.

Dr Zhang Wei is a Principal Scientist and heading Downstream Processing Group (DSP) in Bioprocessing Technology Institute (BTI), Agency for Science, Technology and Research (A*STAR) in Singapore. Her team focuses on purification process development and product characterization for the production of a variety of biotherapeutics, including monoclonal antibodies, bispecific antibodies, vaccines, viral vectors, mRNA, etc. Her team is also committed to work towards intensified and continuous downstream processing. Her team in BTI actively collaborate with dozens of biopharmaceutical companies and bioprocessing solution providers worldwide, including both leading industrial players and local SMEs.

Dr. Wendi Zhang is a Senior Scientist at AbbVie BioResearch Center in Worcester, Massachusetts, specializing in downstream purification process development for monoclonal antibodies. He received his Ph.D. in Chemical Engineering from Rensselaer Polytechnic Institute, where he advanced the theory, implementation and application of downstream monoclonal antibody purification process development. His work combines mechanistic modeling, numerical methods, ML and experimental innovation. Dr. Zhang has published in leading journals such as Computers & Chemical Engineering, Advanced Functional Materials, Biotechnology and Bioengineering and has presented at many national meetings.

Xiaolei Zhuang is a senior scientist II in Global Biologics at USP, who focuses on reference standard development. Before joining USP, she had been working on analytical and preclinical/clinical studies to support biological drug development in biopharmaceutical companies.