Risk Mitigation in Cell Line Development
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.
Merck
Head Upstream, Process Materials and Process Consultancy, APEC
Janice Tan heads the upstream, process materials and process consultancy team in Merck Asia Pacific excluding China. She and her team of scientists and engineers are responsible for providing technical consultation on upstream bioprocessing, bioprocess manufacturing optimization and troubleshooting. With over 23 years of experience in the biopharmaceutical industry, she has led multiple successful projects starting from cell line development to bioreactor scale-up by presenting holistic and innovative solutions to customers producing biotherapeutics. 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
기간:1h
언어:English
세션 1:발표 완료 December 7, 2021