The bioprocessing industry has identified an urgent need to intensify downstream operations, making them smaller, faster, and more cost-effective. While numerous technologies and techniques exist to intensify individual unit operations, implementing an integrated next-generation bioprocess presents significant challenges. Our collaboration with Transcenta has culminated in the development of a state-of-the-art, highly automated bioprocessing train for the manufacture of monoclonal antibodies and other biologics.
This webinar will detail the bioprocessing template, operational paradigm, and the complexities involved in qualifying such an advanced manufacturing method.
In this webinar, you will learn:
- What constitutes an intensified bioprocess,
- Transcenta's template for next-generation bioprocess capability,
- The installation and qualification of a multi-column chromatography system and a flow-through polishing system,
- Strategies for managing and qualifying long-duration bioprocessing challenges, such as bioburden control.
Speakers
Jérome Dalin
Merck
Associate Director – Alliance Management, BioContinuum™ Business Franchise
Jerome Dalin holds an Msc/engineering degree in industrial manufacturing and biological engineering. He started his career at Sanofi Pasteur 21 years ago, focusing on vaccine process development in France, Canada & USA. In 2013, he joined our company to manage bioprocessing sales and later transitioned to the Strategy organization to lead global initiatives for vaccines and the Factory of the Future. In his current role, Jerome is at the helm of Alliance Management, driving the development of the BioContinuum™ platform across the biopharmaceutical industry.
Kara Pizzelli
Merck
Downstream Process Strategic Product Manager, Biocontinuum™ Business Franchise
Kara Pizzelli holds an MSc degree in chemical engineering. Her career started at our company 25 years ago, focusing on the optimization and scale-up of the unit operations from clarification to bulk drug filtration for customers in the US. Kara more recently managed the global clarification business, owning the strategy and innovation, before taking on the role of DSP Strategic Product Manager in the Biocontinuum™ Business Franchise in 2023.
Chris Hwang
Transcenta
EVP, CTO
Chris Hwang holds a Ph.D. in biochemical engineering from MIT and has more than 30 years of experience in the biopharmaceutical industry. He began his career at Genzyme and later at Sanofi, supporting and leading CMC development as well as process and technology development. He also served as project lead for the Integrated Continuous Biomanufacturing platform program. Chris joined HJB/Transcenta in 2016, where he is responsible for CMC development and developing and industrializing highly intensified biomanufacturing platforms to increase facility output, enhance process control, and reduce the cost of goods to expand patient access to innovative biologics.
Jewell Zhou
Transcenta
Lead Scientist – CMC Process Development, Downstream Platform
Jewell Zhou holds an Msc/engineer degree in biology and bioprocessing engineering. He joined the HJB company in 2018 as a scientist to develop downstream purification process for CMC. In 2020, he joined the HJB HiCB group and started to build and support continuous purification platform for advanced antibody manufacturing. In his current role, Jewell is working on HICB/Transcenta platform development and supporting continuous manufacturing control strategy.
Paul Beckett
Merck
Senior Manager, Downstream Technologies, BioContinuum™ Platform
Paul holds a B.S. in biochemistry from Imperial College London and has an M.S. and Ph.D. in biochemical engineering from University College London. Paul has worked in the pharmaceutical industry for 20 years and has held a number of roles in this capacity, including managing bioprocesses for early phase clinical material, CMC regulatory affairs consultancy, and downstream bioprocessing technology consultancy. Currently, Paul is a senior manager responsible for the DSP strategy for the BioContinuum™ next-generation processing platform.
Pharma and biopharma manufacturing
- Downstream Processing
Duration:1h
Language:English
Session 1:presented June 27, 2024
To continue reading please sign in or create an account.
Don't Have An Account?