Cambridge Healthtech Institute ’s 3rd Annual

Continuous Processing for Biopharmaceuticals
(생물의약품을 위한 연속 프로세스)

프로세스의 강화, 통합, 제어의 개선

2020년 3월 24 - 25일

 

생물의약품을 위한 연속 프로세스를 테마로 한 이 컨퍼런스 프로그램에서는 업스트림 공정과 다운스트림 공정에서 연속 프로세스의 기술 개발, 통합, 실용화시 실용적인 문제에 초점을 맞춥니다. 이번에 다루어지는 토픽은 관류에서 정제에 이르까지 연속 프로세스의 개발, 프로세스의 제어, 견고성과 모니터링, 바이러스 안전성, 비용 분석, 상업화를 위한 생산 향상 등이며, 모두 국제적 규제에 준거하여 논의됩니다.

Final Agenda

3월 23일(월)

Recommended Short Course*

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

Instructor: Margit Holzer, PhD, Owner, Ulysse Consult

*Separate registration required.

3월 24일(화)

7:00 Registration and Morning Coffee

프로세스 모델링과 디지털화

8:25 Chairperson’s Opening Remarks

Margit Holzer, PhD, Owner, Ulysse Consult

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

Andrew_SinclairAndrew Sinclair, President & Founder, 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.

11:45 Sponsored Presentation (Opportunity Available)

12:15 Luncheon Presentation to be Announced

13:00 Session Break

백신과 다운스트림 공정에서의 연속 프로세스

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 FEATURED PRESENTATION: High-Throughput Methodologies for Integrated Continuous Processing

Ottens_MarcelMarcel Ottens, PDEng, Associate Professor, Bioprocess Engineering, TU Delft


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

Pezzini_JeromeJérôme Pezzini, 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_L_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 Viewing

18:30 End of Day

3월 25일(수)

8:00 Registration and Morning Coffee

관류 프로세스의 통합, 자동화, 진보

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 Presentation to be Announced

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

 

전체 기조 세션:차세대 프로세스와 제품

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 to be Announced

 

13:00 End of Continuous Processing for Biologics

* 주최측 사정에 따라 사전 예고없이 프로그램이 변경될 수 있습니다.

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