GMP or not? Understanding raw material quality grades and requirements for ATMP manufacturing

Tuesday 09:00 PDT / 12:00 EDT / 16:00 GMT / 17:00 CET

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GMP or not? Understanding raw material quality grades and requirements for ATMP manufacturing

Live30 webinars are thirty-minute presentations designed to update you on the latest innovations, applications, and data in a fast yet interactive format.

While regulatory bodies provide guidance on raw/ancillary and starting material quality and risk assessment for ATMP development, the responsibility for qualifying materials ultimately falls on developers. This webinar will explore key quality standards and terminology for ATMP raw/ancillary and starting materials, with the aim of equipping developers with the knowledge needed to streamline sourcing, qualification, and utilization of these materials in ATMP manufacturing.

The concept of 'raw/ancillary and starting material quality grade' is a critical topic for ATMP developers, but there is currently significant ambiguity and misunderstanding surrounding it – attend this webinar to review key definitions of GMP/cGMP as per regulations, and explore the applicability of GMP/cGMP to raw/ancillary and starting materials.

Attend this webinar to:

Review key pitfalls and misconceptions surrounding material quality grades and requirements
Understand key elements of the appropriate quality standards and requirements for raw/ancillary and starting materials
Explore recommendations for industry for establishing broadly acceptable criteria for raw/ancillary and starting material quality and management

Lili Belcastro

Associate Director - Cell Therapy Development Raw Materials at Bristol-Myers Squibb

Dr. Lili Belcastro is an Associate Director at Bristol-Myers Squibb, where she leads the Early Development Raw Materials group within Cell Therapy Development. With over fifteen years of experience, Dr. Belcastro specializes in preclinical and clinical cancer biology, cell and gene therapy product development, and method development. Her expertise spans a wide range of complex biological molecules, small molecule inhibitors, ancillary materials, starting materials, and gene editing materials. Dr. Belcastro also sits on the USP expert panel drafting the plasmid starting material chapter and participates in the development of various cell and gene therapy standards. She earned her PhD in cancer biology through a joint program between the University of the Sciences (now Saint Joseph’s University) and The Wistar Institute in Philadelphia.

Basak Clements

Founder/Senior Scientific Advisor at Biomatria Consulting LLC

Basak Clements, PhD, is the Founder and Senior Advisor at biomatria, a scientific consultancy specializing in materials science and management for the biopharmaceutical and advanced therapy industries. With over 15 years of experience, Basak is a seasoned biopharmaceutical development leader, driving innovation in cell and gene therapy (CGT), biologics manufacturing, and materials science. As a Senior Advisor at biomatria, she provides strategic consulting to biopharmaceutical companies, research institutions, suppliers and CDMOs, with a focus on raw, starting and single-use material management for biologics and advanced therapies.

Claire Wartel

Director of Regulatory Affairs at Sartorius

Claire has a PhD in molecular pharmacology and pharmacochemistry from the University of Strasbourg (France). After several post-doctoral positions, Claire joined Polyplus (Illkirch-Graffenstaden, France) in 2004 as a Cell Biology Project Leader and helped develop the company’s flagship product, jetPRIME® transfection reagent. Today, Claire manages the Department of Regulatory Affairs at Sartorius-Polyplus.