Original Agenda
We are actively working with our speakers to confirm their availability for our new dates. Initial response from our speakers has been very positive, and we are optimistic we will have the new programs ready to share here soon.

Cambridge Healthtech Institute ’s 3rd Annual

Continuous Processing for Biopharmaceuticals

Improving Process Intensification, Integration and Control

New Dates - 21-22 JULY 2020

 

Continuous bioprocessing is an efficient way for companies to improve productivity and facility utilization. But what are the practical considerations to consider, which technology gaps still remain, and how can industry ensure process control and stability at scale?

Cambridge Healthtech Institute’s Continuous Processing for Biopharmaceuticals conference focuses on the practical challenges of developing, integrating and implementing continuous processing across upstream and downstream processing. Key topics include continuous process development from perfusion to purification, process control, robustness and monitoring, viral safety, cost analysis and ramping up production for commercialization, all in line with international regulations.

Final Agenda

Monday, 23 March

Recommended Short Course*

13:00 - 16:00 SC1: Continuous and Integrated Bioprocessing Masterclass

Instructor: Margit Holzer, PhD, Owner, Ulysse Consult

*Separate registration required.

Tuesday, 24 March

7:00 Registration and Morning Coffee

PROCESS MODELLING AND DIGITALIZATION

8:25 Chairperson’s Opening Remarks

Margit Holzer, PhD, Owner, Ulysse Consult

8:30 Intensive Manufacturing: What Are the Economic Drivers?

Rob Noel, Marketing Consultant, Biopharm Services Ltd.

We are at an interesting pivot point in bioprocessing where there is a keen interest in the intensification of BioPharm manufacturing. Improving flexibility, minimizing risk and reducing cost are the key drivers. In this talk, we use advanced whole bioprocess models to understand the drivers and impact of these different modalities.


9:00 KEYNOTE PRESENTATION: Digitalization Platform and Supervisory Control for Continuous Integrated Manufacture of Monoclonal Antibodies

Massimo Morbidelli, PhD, Professor, Chemical and Bioengineering, ETH Zurich

We present an automated end-to-end integrated platform for the production of a monoclonal antibody. The process consists of a perfusion bioreactor, a continuous protein A capture step, which is followed by low-pH virus inactivation, and frontal and flow-through chromatographic steps for final polishing. The presented results will show the need for an efficient process data collection and hierarchical control system to handle process perturbations and drifts, facilitating robust product yield and quality.

9:30 Biopharmaceutical Process Models in the Digital Age – How to Make Value out of Data

Michael_SokolovMichael Sokolov, PhD, Lecturer, Institute of Chemical and Bioengineering, ETH Zurich; COO and Co-Founder, DataHow

The presentation will address central challenges in digitalization and big data analytics in biopharma and will demonstrate the potential to provide systematically value through integration of smart digital technologies into the work stream. The presentation will be based on several industrial use cases in USP and DSP showing benefits from software-assisted and -enabled process monitoring, control, optimization and automation.

10:00 Grand Opening Coffee Break in the Exhibit Hall with Poster Viewing

10:45 Model-Based Control and Integrated Biomanufacturing Processes

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

In an integrated continuous biomanufacturing process, the unit operations are interlinked. The exit mass flow is the inflow of the following one. The process disturbances are propagating throughout the entire process. RTD based models are the fundamentals to control such complex processes. The effect of surge tanks and periodic quasi-continuous operations will be demonstrated.

11:15 Mapping of PAT Tools for Enabling Integrated DSP in Continuous Biomanufacturing

Dejan_ArzensekDejan Arzenšek, PhD, Principal Scientist, Global Drug Development, Technical R&D, Novartis

The discussion will be focused around the exploration of multiple techniques and their possibilities to secure tight control of the major critical quality attributes (CQA) and different PAT tools for measuring different attributes in (near) real-time. A feasibility study of PAT tools covered in this talk demonstrates the technology for in-line measurements in fed-batch process steps and potential of their use in a continuous process.

Fujifilm-Diosynth-Logo 11:45 SymphonX™:  Disruptive Multi-functional Downstream Bioprocessing for Batch and Continuous Operations

Jonathan HaighJonathan Haigh, PhD, Senior Director, Bioprocess Strategy & Development, FUJIFILM Diosynth Biotechnologies

SymphonX™ is a multi-functional bioprocess system capable of a range of downstream process unit operations. Advanced automation enables SymphonX™ to be deployed in both traditional (batch) and future (continuous) modes of biomanufacturing. This presentation introduces the technology and examples capability through a proof-of-concept continuous biomanufacturing facility. Apollo™-X mammalian cell system, operated in a 500L perfusion bioreactor, connected to seven SymphonX™ units,  will aim to generate ~15kg purified monoclonal antibody over a 30 day process.  

Novasep 12:15 LUNCHEON PRESENTATION: BioSC Pilot and DSP Integration

Flouquet_ThomasThomas Flouquet, Product Manager, Columns & Application Specialist, BioSC, Novasep

A presentation about: BioSC Pilot capabilities for process integration. BioSC pilot programming and monitoring. BioSC Pilot achievements 


13:00 Session Break

CONTINUOUS PROCESSING IN VACCINES AND DSP

13:30 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

13:35 FEATURED PRESENTATION: 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.

14:05 Development of Continuous Purification Strategies for Therapeutic Bioparticles

Ricardo Jorge Sousa da Silva, PhD, Senior Scientist, Animal Cell Technology Group, iBET

Novel therapeutic modalities, such as virus-based biologics or exosomes are hailed as potential game-changers for healthcare. The present talk will focus on the challenges faced during the development of continuous purification strategies. Case studies figuring the purification of gene therapy vectors, oncolytic viruses and exomes will be highlighted.

14:35 CO-PRESENTATION: Software to Compare the Easy Process by Sanofi with Traditional mAb Purification

Thomas Prouzeau, PhD, Scientist, DSP Breakthrough Technologies Skill Center, Biopharma Development, Sanofi

Lucrèce Nicoud, PhD, Project Manager, Ypso-Facto

Developing processes for the purification of mAbs has raised substantial interest during the few last years. The classical approach typically involves numerous buffer solutions and operations, including affinity, ion exchange and hydrophobic interaction chromatography. Sanofi has developed an easy purification process that works in full flow-through without protein A, and in a continuous mode with a single buffer solution. A rigorous comparison between these processes is performed using the software Ypso-Proxima®.

15:05 Refreshment Break in the Exhibit Hall with Poster Viewing

15:45 From Frankfurt to CoPACaPAnA and from Development to GMP: A Journey in Continuous Protein A Chromatography

Ötes_OzanOzan Ötes, Purification Engineer, Bioprocess Engineering, Sanofi-Aventis Deutschland GmbH

For the first time to our knowledge, the implementation of a continuous protein A capture process for antibody applications (CoPACaPAnA) embedded in an end-to-end single-use GMP manufacturing process of a multispecific mAb using the Cadence™ BioSMB 350 system was conducted. Moving to a more heterogeneous portfolio of antibodies and fusion proteins, more flexibility and lower expenditure is desired. We demonstrated that employing single-use equipment and continuous processing can be highly beneficial.

16:15 Continuous Virus Inactivation: State-of-the-Art and Case Studies

Duarte_MartinsDuarte L. Martins, PhD Student, BOKU/ACIB, Laboratory of Protein Technology and Downstream Processing, Department of Biotechnology, University of Natural Resources and Life Sciences (BOKU)

Continuous viral inactivation remains a challenge while the biopharma industry moves towards continuous integrated processing. However, in the past few years, different approaches were developed in order to achieve the minimum incubation in continuous mode – the biggest challenge. One such approach is the packed bed reactor, which guarantees a narrow residence time distribution. A case study will be presented and continuous inactivation by low pH and by solvent/detergent will be demonstrated.

16:45 Breakout Discussion Groups

This session provides the opportunity to discuss a focused topic with peers from around the world in an open, collegial setting. Select from the list of topics available and join the moderated discussion to share ideas, gain insights, establish collaborations or commiserate about persistent challenges. Then, continue the discussion as you head into the lively exhibit hall for information about the latest technologies.

Continuous Integrated Biomanufacturing Strategies

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

  • Which information can be used from batch experiments
  • Limits of scale down of integrated process
  • Limits of DOE strategies for optimization of ICB
  • New ways to design an optimize ICBs

Digitalization and Big Data in Biopharma – vice or virtue?

Moderators: Massimo Morbidelli, PhD, Professor, Chemical and Bioengineering, ETH Zurich

Michael Sokolov, PhD, Lecturer, Institute of Chemical and Bioengineering, ETH Zurich; COO and Co-Founder, DataHow

  • Challenges in digitalization in biopharma versus available solutions
  • Added value expected from digitalization and big data analytics
  • Requirements and decisions on team and infrastructure

17:30 Welcome Reception in the Exhibit Hall with Poster ViewingPurolite_Life_Sciences

18:30 End of Day

Wednesday, 25 March

8:00 Registration and Morning Coffee

PROCESS INTEGRATION, AUTOMATION AND ADVANCES IN PERFUSION

8:25 Chairperson’s Remarks

Michael Sokolov, PhD, Lecturer, Institute of Chemical and Bioengineering, ETH Zurich; COO and Co-Founder, DataHow

8:30 Developing a Fully Automated, Flexible and Integrated Continuous Downstream Purification Platform and Demonstration of the Production of Three Legacy Batch Processes

Jamieson_StuartStuart Jamieson, PhD, Principal Scientist, Upstream, Downstream and Analytical, CPI Biologics

This presentation will describe the steps taken by a UK-based consortium of biopharmaceutical manufacturers to develop a fully automated and integrated continuous downstream platform. The overarching process control strategy allows a single operator to start up, run and shut down an entire downstream process consisting of up to nine unit operations from capture chromatography through to final formulation.

9:00 Performance Evaluation of a Continuous Antibody Purification Process in a Side-by-Side Comparability Study

Lobedann_MartinMartin Lobedann, PhD, Protein Purification Technology Expert, Bayer AG

Continuous manufacturing (CM) introduces the benefits of cost efficiency, reliability and scalability for the manufacturing of biopharmaceuticals. In combination with disposable equipment closed processing is feasible. Bayer’s unique CM platform consists of a series of downstream processing (DSP) unit operations through which the drug substance moves continuously, where critical process parameters are monitored and controlled in real-time. Reduced manual interference will also lead to reduction of operator errors and according deviations. The presentation also illustrates comparability of CM versus batch processing in a side-by-side approach covering process information, real-time analysis as well as quality data from intermediates and final drug substance.

9:30 Overcoming Obstacles in Perfusion Processes

Goralczyk_VickyVicky Goralczyk, PhD, Director, Cell Line and Bioprocess Development, Glycotope GmbH

Whereas batch and fed-batch processes are common for the production of therapeutics, perfusion is a rediscovered trend in biotechnology. With Glycotope’s decade-long expertise in perfusion cultivation, we share obstacles and difficulties for these processes from an R&D point of view and provide a head-to-head comparison of a CHO-fed-batch to a GEX® (Glycotope’s proprietary human cell line) perfusion process for a difficult to express protein.

9:45 HDPB: Scale Down Model and Process Development

Garcia_DavidDavid Garcia, PhD, Advanced Process and Manufacturing Technologies, Novartis Pharma

The HDPB technology concept has enabled a 1000L disposable bioreactor (reaching 3-4 fold higher cell densities with respect to fed batch) to produce on average 6-10 fold more product, per liter reactor, relative a commercial fed-batch bioreactor. So far, we have developed the process at lab scale for multiple products, including 2 NBE (new biological entity) and 2 Legacy molecules. Each of the HDPB processes demonstrated consistent process performance and product quality from lab to manufacturing scale. A general overview of the scale-down model (SDM) development and process development workflow will be given.

10:00 CO-PRESENTATION: At-line Monitoring of CCTC for mAB Capture and Polishing - A Vision for a Fully Integrated Continuous Bioprocess

Hofer AlexandraAlexandra Hofer, PhD, Business Division, PIMS & PAT, Securecell AG

Oleg Shinkazh, President, CEO, Chromatan

Continuous Countercurrent Tangential Chromatography (CCTC) is a new column-free continuous purification platform that provides an alternative to column chromatography. We will show its application for the development of a fully integrated continuous downstream process for initial ProA capture as well as polishing. The platform is completed with PAT tools (e.g. automated sampling and on-line HPLC) which can provide timely process information and may enable feedback control for CQAs such as high molecular weight species.


10:30 Coffee Break in the Exhibit Hall with Poster Viewing

 

PLENARY SESSION:

NEXT-GENERATION PROCESSES AND PRODUCTS

11:15 Chairperson’s Remarks

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

11:20 Current Opportunities and Challenges in Biotherapeutic CMC

Schumacher_RalfRalf Schumacher, PhD, Global Head, Development Biologicals, Boehringer Ingelheim Pharma GmbH & Co. KG

As biologic pipelines continue to grow and diversify, there is an increasing need to standardize, automate and find efficiencies along the entire value chain. This presentation will discuss the current challenges and opportunities in biotherapeutic CMC and the impact new modalities are having on upstream and downstream processing, analytics and formulation. The advantages of predictive process parameters in early stage development and digital development concepts to speed up the CMC development will also be discussed.

11:50 Gene Therapy Manufacturing and Technical Development

Diane_BlumenthaDiane 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.

12:20 Session Break

Purolite_Life_Sciences 12:30 BRIDGING LUNCHEON PRESENTATION: Batch, Continuous or Intensified Batch Processing – An Innovative Protein A Design to Capture Them All

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.

13:00 End of Continuous Processing for Biologics