Raw materials of biological origin: navigating regulatory requirements for cell therapies

The rapidly growing number of cell therapies entering and progressing through the clinic is translating to increased regulatory requirements for raw materials. The quality, consistency, and safety of raw materials of biological origin (e.g. cells, serum, growth factors, cytokines, antibodies, and enzymes) must all be documented and available for regulatory review, particularly at the BLA stage.

This webinar will explore the specific regulatory requirements of different regions (including analysis of the amount of time the regulatory approval process takes in each case), and improve attendees’ understanding of the critical quality attributes (CQAs) of cell therapy raw and starting materials. The importance of a risk-based approach to raw material sourcing will be emphasized, as will the importance of harmonization and standardization of processes and protocols in cell therapy.   

Attendees will grow their understanding of:

• Global regulatory requirements pertaining to cell therapy raw and starting materials of biological origin
• Differences in raw and starting material GMP compliance and requirements between specific regions
• Harmonization and standardization of raw materials processes and protocols
• Why GMP is particularly important in the context of raw materials of biological origin

Marlin Frechette

Chief Quality & Compliance Officer, FUJIFilm Irvine Scientific

Marlin Frechette has over 25 years of experience in the Medical Device industry, servicing the Pharmaceutical and Biopharmaceutical customers. At Fujifilm Irvine Scientific she is currently the Sr. Director of Quality Systems/Regulatory Affairs/Compliance Officer & ISO Management Representative. At Fujifilm Irvine Scientific she manages and performs review functions of the Quality Systems, Global Regulatory/Product Compliance and Compliance/EHS departments. She holds a Bachelor’s of Science with a major in Business Administration & Personnel Management.

Dominic Clarke

Global Head of Cell Therapy, HemaCare Corporation

Dr. Clarke has over 15 years of experience developing enabling solutions to support cell and gene therapies. He is the Global Head of Cell Therapy at HemaCare, a leading provider of source material for clinical development and commercial manufacturing of cell-based therapies. Previous roles include, Global Product Manager for Charter Medical’s cell therapy and bioprocessing single-use systems portfolio and Director of Research and Development for BioLife Solutions.

Dominic currently serves as the co-chair for the International Society for Cell and Gene Therapies Process and Product Development Committee with efforts directed towards translating research and process development from bench to clinic.

SPEAKERS

Marlin Frechette

Chief Quality & Compliance Officer, FUJIFilm Irvine Scientific

Dominic Clarke

Global Head of Cell Therapy, HemaCare Corporation

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