Chinese Hamster Ovary (CHO) cells are the preferred host for producing biotherapeutics where cell line development (CLD) is the foundation of the bioprocess. CLD processes are expected to be robust while meeting a myriad of regulatory requirements. The choice of the production cell line, culture conditions, and having a chemically defined (CD) CLD process by using CD cloning media can impact the subsequent measures for the CMC (chemistry, manufacturing, and controls). In this presentation, we will discuss these choices and their impacts on subsequent bioprocess and CMC testing required by regulations and the benefits of incorporating CD cloning media into the CHOZN® expression platform.
In this webinar, you will learn about:
- Risk assessment approaches in upstream process development
- How early cell line development stage is linked to subsequent steps in the bioprocess to assure the quality of the final product
- Benefits of having a completely chemically defined cell line development process
Speakers
Janice Tan, Ph.D.
Merck
Head of Upstream MSAT, APAC excluding China
Janice Tan heads the upstream MSAT (manufacturing sciences & technology) team in Asia Pacific, excluding China. She and her team are responsible for providing application and technical consultation on upstream bioprocesses as well as presenting holistic and innovative upstream solutions to customers. Prior to joining, she was involved in developing customized media and feed formulations and applying multi-omics technologies for cell line engineering, media, and process development. Janice received her Ph.D. in biochemistry from the National University of Singapore.
Edmund Ang, Ph.D.
Merck
Senior Technical Expert, APAC
Edmund Ang, a senior technical expert, joined Merck's BioReliance biosafety testing in 2017. He provides technical support on CMC testing of biotherapeutics to biopharma developers and manufacturers in Asia Pacific. He holds a Ph.D. in cell biology from the University of Edinburgh and conducted his postdoctoral research on cell signaling at Stanford University and National Cancer Centre, Singapore.
Pharma and biopharma manufacturing
- Cell Line Development
Duration:1h
Language:English
Session 1:presented December 7, 2021
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