Cambridge Healthtech Institute ’s 3rd Annual

Advances in Recovery and Purification

Optimizing DSP, Reducing Costs

New Dates - 22-23 JULY 2020

 

As product pipelines diversify away from traditional mAbs, downstream processing teams are under increasing pressure to develop new recovery and purification platforms for more complex products, such as bispecifics, ADCs, viral vectors, while at the same time reducing timelines, costs and bottlenecks for traditional mAbs therapies.

Cambridge Healthtech Institute’s Advances in Recovery and Purification conference brings together industry and academia to discuss the latest developments in the capture, recovery and purification of biotherapeutics – mAb and non-mAb – with data-driven case studies on next-generation technologies and strategies in affinity chromatography, clarification, depth filtration, automation, HTPD, new membranes, flocculation, as well as DSP strategies for emerging modalities, such as fragments, bispecifics, gene therapies and vaccines. How do your strategies compare?

Final Agenda

Wednesday, 22 july

 

NOVEL DSP APPROACHES

10:40 Chairperson’s Opening Remarks

David O'Connell, PhD, Lecturer in Biotherapeutics, School of Biomolecular & Biomedical Science, University College Dublin

10:45 Optimization and Utilization of an IgG-Binding, Protein A-Based Purification Matrix

Hober_SophiaSophia Hober, PhD, Professor, School of Biotechnology, KTH Royal Institute of Technology

The most common tool used for purification of antibodies is protein A affinity chromatography, a method that offers high productivity and pure protein product. However, elution of captured antibodies requires low pH and that might be deleterious. We have addressed this issue by developing a protein domain displaying calcium-dependent binding to IgG. To evaluate the domain in affinity chromatography, a matrix based on a tetrameric version of this domain was produced. From this column, elution in physiological pH was possible and IgG recovery was shown to be comparable to commercial matrices.

11:05 New Process Development for Purification of Novel Protein Scaffold Library Binders

David_O’ConnellDavid O’Connell, PhD, Lecturer in Biotherapeutics, School of Biomolecular & Biomedical Science, University College Dublin

This presentation will focus on the development of high-affinity, highly-specific diagnostic and therapeutic binding molecules based on the creation of two novel phage displayed libraries of a uniquely stable and hydrophilic protein scaffold. This novel scaffold has molecular properties designed to achieve significant impact as a new generation of powerful tools in areas of clinical need, both as diagnostic and therapeutic entities. Processing of specific candidates will be described.

11:25 Batch, Continuous or Intensified Batch Processing – An Innovative Protein a Design to Capture Them AllPurolite_Life_Sciences

Mark HicksMark Hicks, PhD, R&D, Purolite Life Sciences

With the current trend in biopharmaceutical manufacturing towards high titre, small or continuous cell cultures and continuous chromatography purification, optimisation of resin design is essential to maximise the purification processes. Purolite have designed a novel range of agarose resins using their proprietary jetting technology, focusing on dynamic binding capacity, buffer consumption, process economy, and productivity. Resins include high capacity Protein A and a variety of IEX resins, suited for both continuous and intensified batch processing.

 

11:45 Q&A, Session Wrap-up

12:00 Lunch Break - Come view our virtual Exhibit Hall

PLENARY SESSION:

NEXT-GENERATION PROCESSES AND PRODUCTS

12:25 Chairperson’s Remarks

Jarka Glassey, PhD, Professor, Chemical Engineering, Engineering, Newcastle University

12:30 Continuous Processing for Vaccine Manufacturing: Challenges and Opportunities

Yang-PingYangYan-Ping Yang, PhD, Head of Bioprocess Research & Development, North America, Sanofi Pasteur

Over the last decade, there have been significant investments in continuous manufacturing in the pharmaceutical industry, as it holds great promise to lead the reduction of process steps, smaller footprint, higher product quality, and better pharmaceuticals for patients. While it’s still in its early stage, the vaccine industry has embraced this concept and is ready to explore the full advantages associated with this approach. This presentation explores the challenges and opportunities to make continuous vaccine manufacturing a reality.

12:55 Gene Therapy Manufacturing and Technical Development

Blumenthal_DianeDiane Blumenthal, PhD., Head, Technical Development, Spark Therapeutics

In the past few years, several cell and gene therapy products have gained regulatory approval in the US and EU with many more in the pipeline. Manufacturers of cell and gene therapy products must tackle technological challenges under the pressure of short timelines resulting from streamlined clinical development. This presentation will focus on the key technical development challenges facing the industry as product development programs move the into the later stages of process development and scale-up, process performance qualification and ultimately commercialization.

13:20 Q&A, Session Wrap-up, Host intro to special virtual features

13:35 Break Time to view virtual Exhibit Hall

13:55 Chairperson’s Remarks

Cristina Peixoto, PhD, Head, Downstream Processing Laboratory, IBET

14:00 Astonishing Features of Protein A Affinity Chromatography Resins

Rainer_HahnRainer Hahn, PhD, Associate Professor, Department of Biotechnology, BOKU

Protein A affinity chromatography is the workhorse for antibody purification. Novel media exhibit some amazing features, like extreme pH transitions, which can be triggered by specific buffer selection leading to process conditions that can benefit the respective antibody to be purified. Furthermore, protein A ligand properties can change significantly upon alkaline treatment and eventually lead to enhanced mass transfer.

14:20 Strategies and Advances in Purification of New Therapeutic Modalities

Cristina_PeixotoCristina Peixoto, PhD, Head, Downstream Processing Laboratory, IBET

The last few decades have witnessed a huge development in the design of new virus-based biopharmaceuticals. They have been used for cancer treatment, neurodegenerative and genetic diseases, as well as in immunotherapies. However, their purification still presents challenges related to the high dosages and high purity required. New insights on how the additive manufacturing and new affinity matrices improve the global recoveries are presented and discussed.

14:40 Minimizing Resources in Developing Commercial Virus Filtration Processes with Planova™ BioEXAsahi_Kasei_Bioprocess

Dayani_RoyaRoya Dayani, Senior Product Manager, Asahi Kasei Bioprocess Europe

Establishing a virus filtration step in biopharmaceutical development and manufacturing process may require a large number of resources. These can be minimized with swift process development, smooth scale-up, and worry-free operations. In this presentation, you will learn through different case studies the filtration performances of PlanovaTM BioEX with regards to robustness, scalability, flexibility, and consistency, even in challenging conditions. Contribution to rapid cost-effective process development during different clinical phases will be also explained.

15:00 Q&A, Session Wrap-up

15:15 Virtual Happy Hour in our Virtual Exhibit Hall

 

Thursday, 23 july

 

PURIFICATION OF NOVEL THERAPIES

9:00 Chairperson’s Remarks

Alois Jungbauer, PhD, Professor, Department of Biotechnology, University of Natural Resources and Life Science, Vienna, Austria and Austrian Centre of Industrial Biotechnology

9:05 Critical Factors for the Precipitation of Monoclonal Antibodies

Dutra_GregGregory Dutra, PhD Student, Department of Biotechnology, BOKU

Continuous antibody precipitation combined with tangential flow filtration allows a constant mass flow process. Fine-tuning the conditions is imperative for achieving acceptable recovery and purity rates. Using a cross-linking agent as the main precipitant, we describe the critical factors and its effects on the precipitation of different recombinant monoclonal antibodies.

9:25 In-Line Buffer and Media Reconstitution from Solids

Komuczki_DanielDaniel Komuczki, PhD Candidate, Institute of Bioprocessing Science and Engineering, Working Group Jungbauer, BOKU

Integrated continuous biomanufacturing requires big hold tanks for buffer and media preparation. The current trend to reconstitute from stock solutions is especially problematic for fermentation media. We show a proof-of-concept for a continuous reconstitution of media and buffers from solids in lab scale. This opens a new playground for development of strategies in upstream and downstream and several applications of this concept will be demonstrated.

9:45 CO-PRESENTATION: Enhancing Continuous Processing: Implementation of Chromatographic Clarification Advantages and Approaches3M

El-Sabbahy_HaniHani El-Sabbahy, PhD, Biopharmaceutical Application Engineering Specialist, Separation and Purification Sciences Division, 3M United Kingdom PLC, 3M

Ariadna Padrós, Key Account Manager, Application Engineer Separation and Purification, Separation and Purification Sciences Division, 3M

A number of commercial and academic entities are exploring continuous processing for recombinant protein manufacturing. It has the potential to bring many advantages to the production of biotherapeutics such as; lower capital costs, higher productivity, smaller equipment footprint, lower buffer consumption, and, in some circumstances, steady state operation. However, one of the key barriers to implementation, particularly with respect to the continuous capture step, is system complexity. 

10:05 Q&A, Session Wrap-up

10:20 Break Time to View our Virtual Exhibit Hall

10:45 Chairperson’s Remarks

Alois Jungbauer, PhD, Professor, Department of Biotechnology, University of Natural Resources and Life Science, Vienna, Austria and Austrian Centre of Industrial Biotechnology

 

10:50 Purification Considerations for Plasmid DNA to Enable Gene Therapies

Les_KarolinaKarolina Les, PhD, Scientist II, R&D Biopharmaceuticals, Purification Process Scientist, AstraZeneca

Development of next-generation medicines to treat or cure some of the most serious of human diseases is on the near horizon. Majority of treatments rely on recombinant proteins, however this landscape is now changing to include oligonucleotides and viral delivery technologies. This presentation will focus on the critical considerations around the development of a scalable manufacturing process to produce plasmid DNA as final product or intermediate to gene therapies.

11:10 Downstream Processing of Influenza Virus like Particles

Alois_JungbauerAlois Jungbauer, PhD, Professor, Department of Biotechnology, University of Natural Resources and Life Science, Vienna, Austria and Austrian Centre of Industrial Biotechnology

 

11:30 Sponsored Presentation (Opportunity Available)

11:50 Q&A, Session Wrap-up

12:05 Lunch Break, Virtual Exhibit Hall

 

NOVEL PURIFICATION AND DIGITAL PLATFORMS

12:30 Chairperson’s Remarks

Alois Jungbauer, PhD, Professor, Department of Biotechnology, University of Natural Resources and Life Science, Vienna, Austria and Austrian Centre of Industrial Biotechnology

 

12:35 Developing a Continuous Non-Chromatographic Purification Stage for Monoclonal Antibodies

Philip Corner, PhD, Scientist, Technical Lead, CPI Biologics

A gram-scale prototype employing membrane assisted crystallisation has been developed for the single step purification of monoclonal antibodies. Learnings and results from purifying a model monoclonal antibody using this prototype are guiding the development of scale-up and transition to continuous purification using the same technology, progressing towards the goal of improving efficiencies in the downstream processing of therapeutic proteins.

12:55 A Microfluidic Platform for Biopharmaceuticals Manufacturing Optimization

Baros_RaquelRaquel Aires-Barros, PhD, Professor, Bioengineering, Instituto Superior Técnico

The number of biotechnology-based pharmaceuticals in the late-stage pipeline has been increasing more than ever; in particular monoclonal antibodies (mAbs) represent a quarter of all biopharmaceuticals in clinical trials. As a result, there is an enhanced demand for more efficient and cost-effective processes. Here, the potential of miniaturization as a high-throughput screening tool to speed up process optimization is explored, considering optimization of antibody extraction conditions with ATPS and chromatographic conditions optimization using a multimodal ligand.

13:15 A Digital Downstream Process – Specification-Driven Intermediate Acceptance Criteria Using a Digital Twin

Marschall_LukeLukas Marschall, Exputec GmbH

The most commonly applied approach for intermediate acceptance range definition, a 3-sigma range, leads to higher out-of-specification probabilities and a restrained manufacturing flexibility. Using a digital twin – with the same amount of data – we derive specification-driven acceptance criteria that ensure a predefined out-of-specification probability. These specification-driven ranges enable us to set up a control strategy that prevents failed batches while maintaining the highest possible manufacturing flexibility.

13:35 Q&A, Session Wrap-up

13:50 Break Time to view our Virtual Exhibit Hall

14:05 Breakout Discussion Groups

15:05 Close of Summit



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