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Risk Mitigation in Cell Line Development: Regulatory Considerations and Impact on Quality Assurance



WEBINAR

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.

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.

Edmund Ang, Ph.D.

Merck

Senior Technical Specialist

Edmund Ang is a senior technical specialist who provides technical support to biopharma developers and manufacturers in Asia Pacific. He has extensive life science R&D experience in cancer drug and biomarker discovery at Eli Lily and Ionis Pharmaceuticals, as well as commercial experience in cellular analysis and bioproduction with Roche Diagnostics, Life Technologies, and Thermo Fisher Scientific. 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.