Cambridge University Press Continuous Biopharmaceutical Processes
- Day 1
- Day 2
- Download Brochure
Tuesday, 21 July
09:00
Process Modelling and Digitalization Overview
Margit Holzer, PhD, Owner, Ulysse Consult
09:05
Intensive Manufacturing: What Are the Economic Drivers?
Andrew 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.
09:25 KEYNOTE PRESENTATION:
Digitalization Platform and Supervisory Control for Continuous Integrated Manufacture of Monoclonal Antibodies
Massimo Morbidelli, PhD, Professor, Department of Chemistry, Materials and Chemical Engineering, Politecnico di Milano
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 results 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.
09:45 PANEL:
Q&A with Speakers
Panel Moderator:
Margit Holzer, PhD, Owner, Ulysse Consult
Panelists:
Andrew Sinclair, President & Founder, BioPharm Services Ltd.
Massimo Morbidelli, PhD, Professor, Department of Chemistry, Materials and Chemical Engineering, Politecnico di Milano
Michael Sokolov, PhD, Lecturer, ETH Zurich; Co-Founder and COO, DataHow AG
10:25 Coffee Break - View our Virtual Exhibit Hall
10:55
Biopharmaceutical Process Models in the Digital Age – How to Make Value out of Data
Michael Sokolov, PhD, Lecturer, ETH Zurich; Co-Founder and COO, DataHow AG
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 Jungbauer, PhD, Professor & Head, Biotechnology, Institute of Bioprocess Science and Engineering, University of Natural Resources and Life Sciences (BOKU)
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.
A tool for process intensification through multistep integration.
Brief overview of control strategy and case study results.
11:55 PANEL:
Q&A with Speakers
Panel Moderator:
Margit Holzer, PhD, Owner, Ulysse Consult
Panelists:
Alois Jungbauer, PhD, Professor & Head, Biotechnology, Institute of Bioprocess Science and Engineering, University of Natural Resources and Life Sciences (BOKU)
Michael Sokolov, PhD, Lecturer, ETH Zurich; Co-Founder and COO, DataHow AG
12:10 Lunch Break - View our Virtual Exhibit Hall
12:45
From Frankfurt to CoPACaPAnA and from Development to GMP: A Journey in Continuous Protein A Chromatography
Ozan Oetes, 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 J.S. Silva, PhD, Senior Scientist, Downstream Process Development, Animal Cell Technology, iBET Instituto de Biologia Experimental Tecnologica
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 PANEL:
Q&A with Speakers
Panel Moderator:
Alois Jungbauer, PhD, Professor & Head, Biotechnology, Institute of Bioprocess Science and Engineering, University of Natural Resources and Life Sciences (BOKU)
Panelists:
Ozan Oetes, Purification Engineer, Bioprocess Engineering, Sanofi Aventis Deutschland GmbH
Ricardo J.S. Silva, PhD, Senior Scientist, Downstream Process Development, Animal Cell Technology, iBET Instituto de Biologia Experimental Tecnologica
13:40 Refresh Break - View our Virtual Exhibit Hall
14:00
Performance Evaluation of a Continuous Antibody Purification Process in a Side-by-Side Comparability Study
Bastian Budde, PhD, PH Biological Development, 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.
14:20
Continuous Virus Inactivation: State-of-the-Art and Case Studies
Duarte L. Martins, University of Natural Resources and Life Sciences (BOKU), Vienna
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.
14:40 PANEL:
Q&A with Speakers
Panel Moderator:
Alois Jungbauer, PhD, Professor & Head, Biotechnology, Institute of Bioprocess Science and Engineering, University of Natural Resources and Life Sciences (BOKU)
Panelists:
Bastian Budde, PhD, PH Biological Development, Bayer AG
Duarte L. Martins, University of Natural Resources and Life Sciences (BOKU), Vienna
14:55 Happy Hour - View our Virtual Exhibit Hall
15:15 Breakout Discussions
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.
COVID Vaccine Manufacturing
Antonio Roldao, PhD, Head of Cell-Based Vaccines Development Laboratory, Animal Cell Technology Unit, Instituto de Biologia Experimental e Tecnológica (iBET)
- Unique Manufacturing Challenges for COVID Vaccines
- Technology Gaps
- DNA versus vector-based Production
- Upcoming Developments
Manuel JT Carrondo, Professor, Chemical & Biochemical Engineering, Univ Nova de Lisboa, IBET
Digitalization and Big Data in Biopharma – vice or virtue?
Alois Jungbauer, PhD, Professor & Head, Biotechnology, Institute of Bioprocess Science and Engineering, University of Natural Resources and Life Sciences (BOKU)
- Challenges in digitalization in biopharma versus available solution
- Added value expected from digitalization and big data analytics
- Requirements and decisions on team and infrastructure
- Application in Continuous Processing
Michael Sokolov, PhD, Lecturer, ETH Zurich; Co-Founder and COO, DataHow AG
Massimo Morbidelli, PhD, Professor, Department of Chemistry, Materials and Chemical Engineering, Politecnico di Milano
16:15 Close of Day
- Day 1
- Day 2
- Download Brochure
Wednesday, 22 July
09:05
Developing a Fully Automated, Flexible and Integrated Continuous Downstream Purification Platform and Demonstration of the Production of Three Legacy Batch Processes
Stuart Jamieson, PhD, Head, Research, 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.
09:25
Overcoming Obstacles in Perfusion Processes
Vicky Goralczyk, PhD, Director, Cell Line & 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.
09:45 PANEL:
Q&A with Speakers
Panel Moderator:
Michael Sokolov, PhD, Lecturer, ETH Zurich; Co-Founder and COO, DataHow AG
Panelists:
Stuart Jamieson, PhD, Head, Research, CPI Biologics
Vicky Goralczyk, PhD, Director, Cell Line & Bioprocess Development, GLYCOTOPE GmbH
10:20 Coffee Break - View our Virtual Exhibit Hall
10:45
Optimization and Utilization of an IgG-Binding, Protein A-Based Purification Matrix
Sophia 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'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 PANEL:
Q&A with Speakers
Panel Moderator:
Cristina C. Peixoto, PhD, Head Downstream Process, Animal Cell Technology, iBET Instituto de Biologia Experimental Tecnologica
Panelists:
Sophia Hober, PhD, Professor, School of Biotechnology, KTH Royal Institute of Technology
David O'Connell, PhD, Lecturer in Biotherapeutics, School of Biomolecular & Biomedical Science, University College Dublin
12:00 Lunch Break - View our Virtual Exhibit Hall
Margit Holzer, PhD, Owner, Ulysse Consult
12:30
Continuous Processing for Vaccine Manufacturing: Challenges and Opportunities
Yan-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
Diane I. Blumenthal, Head, Technical Development, Spark Therapeutics Inc.
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 PANEL:
Q&A with Speakers
Panel Moderator:
Margit Holzer, PhD, Owner, Ulysse Consult
Panelists:
Yan-Ping Yang, PhD, Head of Bioprocess Research & Development, North America, Sanofi Pasteur
Diane I. Blumenthal, Head, Technical Development, Spark Therapeutics Inc.
13:35 Close of Continuous Processing for Biopharmaceuticals
- Day 1
- Day 2
- Download Brochure
Source: https://www.bioprocessingeurope.com/20/continuous-processing
0 Response to "Cambridge University Press Continuous Biopharmaceutical Processes"
Post a Comment