Qualification of Raw Materials and Cell Substrates for Biomanufacturing

16th January 2020 | 10.00 am EST | Maura C. Kibbey, Ph.D., Director, Science & Standards, Global Biologics, U.S. Pharmacopeia and Martin Wisher, PhD, Global Head of Regulatory Affairs at Merck |WATCH FOR FREE

The quality of starting materials is critical for successful pharmaceutical manufacturing strategies. For biomanufacturing the challenges are further amplified due to the use of a wide variety of raw materials, cell lines, and naturally-derived materials with an increased risk for the introduction of unwanted impurities and adventitious agents. This presentation will provide an overview and updates on USP documentary standards containing best practices for qualifying incoming materials, demonstrating viral clearance, cryopreservation, cell banking, and controlling impurities derived from cell substrates for therapeutic proteins.

Presented by Maura C. Kibbey, Ph.D., Senior Scientific Fellow, Global Biologics U.S. Pharmacopeia

Dr. Maura Kibbey is a Senior Scientific Fellow for Education and Training in USP’s Global Biologics Department. As USP’s refocused its strategy for biologics standards, Dr. Kibbey has collaborated with scientific experts and trainers to bring many more educational offerings to USP’s stakeholders. Not only to demonstrate the utility of these new standards but to also receive more feedback on future standards for advanced therapies. This role builds on her previous responsibilities directing USP scientists developing compendial standards.  Before joining USP, Dr. Kibbey worked for several biotechnology and diagnostic companies in the Washington DC area in scientific, management, marketing, and business development roles, as well as performing cancer research at the National Institutes of Health. Her scientific expertise includes development and validation of many different assay types for measurement of individual molecules, their activities, or binding interactions. She has published over 40 peer-reviewed articles and has been an invited speaker or workshop organizer for numerous scientific conferences.

And Martin Wisher, PhD, Global Head of Regulatory Affairs at Merck

With more than 30 years of experience in biologics quality control, assay and process validation, Dr. Wisher is well regarded in the biopharmaceutical, vaccine, gene and cell therapy industries. He has written numerous quality and regulatory articles and conducted biologics safety testing workshops and seminars around the world.

Dr. Wisher is currently Vice-Chairman of the Animal Cell Technology Industrial Platform (ACTIP) and has been a Chairman of the PDA Virus Spike Quality working group and a member of WHO and PDA working groups. He has held regulatory leadership positions focusing on the BioReliance® services portfolio since 1990. He obtained his PhD in membrane biochemistry from the National Institute for Medical Research in London and conducted subsequent research on membrane receptors, monoclonal antibodies, and recombinant vaccines.

Sponsored by Merck

Merck, a life science leader, is a business of Merck KGaA, Darmstadt, Germany. Our products and services help you safely and efficiently develop and manufacture therapeutics. Our BioReliance® biosafety services offer comprehensive and integrated services that support every phase of the testing, development and manufacturing process. For more information, please visit www.bioreliance.com

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