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

Tuesday, 21 July

8:55 Welcome Introduction

PROCESS MODELLING AND DIGITALIZATION

9:00 Chairperson’s Opening Remarks

Margit Holzer, PhD, Owner, Ulysse Consult

9:05 Intensive Manufacturing: What Are the Economic Drivers?

Noel_RobRob 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.

9:25 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.

9:45 Sponsored Presentation (Opportunity Available)

10:05 Q&A, Session Wrap-up

10:20 Break Time to View our Virtual Exhibit Hall

10:50 Chairperson’s Opening Remarks

TBC

10:55 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.

11:15 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.

11:35 BioSC Pilot and DSP IntegrationNovasep

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 

 

11:55 Q&A, Session Wrap-up

12:10 Lunch Break - Come and View our Virtual Exhibit Hall

CONTINUOUS PROCESSING IN VACCINES AND DSP

12:40 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

12:45 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.

13:05 Development of Continuous Purification Strategies for Therapeutic Bioparticles

Ricardo_Jorge_Sousa_da_SilvaRicardo 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.

13:25 Q&A, Session Wrap-up

13:40 Break Time to View our Virtual Exhibit Hall

13:55 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

14:00 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.

14:20 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.

14:40 Q&A, Session Wrap-up

14:55 Virtual Happy Hour in our Virtual Exhibit HallPurolite_Life_Sciences

15:15 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

Wednesday, 22 July

8:00 Registration and Morning Coffee

PROCESS INTEGRATION, AUTOMATION AND ADVANCES IN PERFUSION

9:00 Chairperson’s Remarks

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

9:05 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.

9:25 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 Sponsor Presentation (Opportunity Available)

10:05 Q&A, Session Wrap-up

10:20 Break Time to View our Virtual Exhibit Hall

 

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

Hicks_MarkMark 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

BPDE Brochure RC