Abstract

This talk will focus on answering 3 main questions in novel continuous upstream bioprocessing: (1) How can I gain from process intensification with the least effort?,  (2) Should I retrofit my facility to become continuous or not? and (3) Is it possible to introduce intensification changes in late clinical or post commercial phases?

Speaker Bio

John Bonham-Carter is the Director of Upstream Sales at Repligen. John has been a serial entrepreneur with experience in multiple countries in industries from newspapers to biotechnology.  Within bioprocessing, he has worked with many different upstream technologies and, most recently, has propelled the XCell™ ATF System to become the industry leader in continuous culture equipment supply.  John is a regular international speaker on bioprocessing, SME entrepreneurship and business coaching. He is the editor of two eBooks: “Continuous Bioprocessing: Current Practice & Future Potential”  and "Continuous Bioprocessing: Industry Best Practices". John holds a Chemistry Degrees from the University of Bristol.

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Abstract

Innovation team at Merck Serono is currently developing a continuous purification platform to fully support the significant improvement of cell culture processes productivity. This presentation will emphasize the benefits of pre-packed technologies from Repligen for the development of Merck's continuous purification process. It will take the audience on a journey from robot assisted early development to final trials of the process at pilot scale, highlighting how Repligen's solutions eased and facilitated several development activities.

Speaker Bio

Victor Pasquier is a process engineer specialized in protein purification at Merck Healthcare in Corsier-sur-Vevey, Switzerland. Since 2016, Victor is involved in technological and process innovation activities at Merck, including chromatography-related projects, process intensification, and next-generation processes development. Victor received his M.Sc. in biotechnology from the engineering school CPE Lyon, France.

Abstract

Pre-packed chromatography columns have been commonly adapted in industry during the recent years, however data showing scalability throughout various column sizes applied in early stage process development up to commercial manufacturing has been not available so far. This presentation confirms the scalability of column performance throughout Repligen’s OPUS^® Pre-packed column covering a range of 0.5 to 60 cm inner diameter. Scalability has been demonstrated for various resin types and functionalities and has been proven for both column packing performance and protein separation under isocratic conditions. Experimental data on OPUS^® packing performance has been compared to traditional self-packed columns and found at least equal if not better. Furthermore a statistical data analysis using advanced software tools has been performed for more than 30,000 pre-packed columns supplied into global industry over a time span of 10 years. 

Speaker Bio

Tim Schroeder is the Director of Product Management at Repligen responsible for the OPUS^® portfolio of Pre-packed chromatography columns for process development (formerly Atoll pre-packed columns). Before Repligen acquired Atoll GmbH in 2016, Tim was Head of Production at Atoll GmbH and was involved in the development and production of MediaScout^® chromatography columns and the commercial launch of RoboColumn^®. He graduated with a Degree in Dipl.-Ing. from the University of Applied Sciences Aachen, majoring in Biotechnology. His diploma thesis at the Research Center in Jülich, Germany was on the development of RoboColumn® and system integration, for which he received a US patent.

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Abstract

The rising relevance of integrated continuous manufacturing for the production of therapeutic proteins has attracted industry’s interest in mammalian cell perfusion cultures as general production platform for therapeutics. It is generally understood that the development of these processes should be done at the liter scale with further scale-up at commercial scale. However, the large number of cultivations needed in general for the development of a perfusion process requires a mL-scale reactor system that allows mimicking the continuous operation including cell bleeding and cell-free harvesting to reduce associated costs and medium consumption.

Speaker Bio

Dr. Moritz Wolf is a Research Scientist in Professor Morbidelli’s Group at ETH Zurich. He is working on the design, development and optimization strategies for mammalian cell perfusion cultures as part of an end-to-end integrated continuous biomanufacturing platform. Moritz performed his Master Thesis in the metabolic engineering laboratory of Professor Greg Stephanopoulos at MIT. He holds both a Bachelor (2013), Master (2015) and PhD (2018) degrees from ETH Zurich. 

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Abstract

An overview of the use of single use technologies in the purification of biotech products from the initial risk assessment, operational challenges, cost benefit analysis, operational challenges to meeting regulatory expectations. 

Speaker Bio

James Chawke is a Chemical Engineering Consultant for the Biotech industry. He has worked in the start-up of numerous biotech facilities in Ireland & Europe. James has been involved in multiple technical transfers through commissioning, validation, regulatory approval and process improvement of both clinical & commercial products. As a result he has experience in troubleshooting issues from initial bioprocess equipment installation right through to manufacturing operations for US based biotech companies.  James holds a G. Dip Chemical Engineering and BSc Physics & Energy both from the University of Limerick.

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bstract

Scale-down applications of perfusion cell culture are complicated for technical reasons, such as continuous media exchange and cell retention. In this frame, we developed a semi-continuous experiment for screening application, and for the determination of a CSPRmin value. An example with a number of different clones will be presented to illustrate this method. Opportunities of perfusion cell culture will be discussed based on the development of another cell line, expressing a bispecific fusion protein.

Speaker Bio

Jean-Marc Bielser is currently in the PhD program within Merck and in collaboration with the Morbidelli group from ETH in Zürich. Jean-Marc first joined Merck in 2012 as Scientist in the Cell Culture group. He has worked on many upstream projects using different cultivation systems ranging from microliters to 50L pilot scale bioreactors. The projects he was involved with include clone screening, media optimization, and development of the perfusion technology. Jean-Marc received his MSc in Chemical Engineering and Biotechnology at EPFL in 2012 after an industrial internship in Basel and a Master thesis at MIT in Cambridge, MA (USA).

Abstract

Time to market is crucial in process development, and many companies developing and manufacturing therapeutic agents have invested in automated protein purification and high throughput bioprocessing. The miniaturization and parallelization capabilities of Tecan’s liquid handling platforms ensure an excellent understanding of bioprocesses for robust scale-up into manufacturing, enabling cost-effective development.

Speaker Bio

Jana Langhoff is an Application Specialist for cell biology and protein sciences at Tecan. She has been part of Tecan since 2015 where her main focus lay in developing and supporting automated high throughput bioprocessing and  protein purification applications with Repligens OPUS® RoboColumns®. Prior to joining Tecan, Jana was a Development Engineer for Roche Diagnostics. She holds a Master’s of Science in Molecular and Cell Biology from Freie Universität Berlin.

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