Raw Material Sourcing and Qualification


23rd November 2020 | 10:00 am EST | Scott R. Burger, MD, Principal of Advanced Cell & Gene Therapy, LLC |BOOK FREE SEAT FOR THIS WEBINAR

Effective raw materials sourcing, testing, qualification and control are critical for product safety and quality to assure lot-to-lot consistency and functional activity in the manufacturing process. This is more challenging for biological raw materials, such as enzymes, sera, and cytokines, which often cannot be fully defined by testing, and may present risks related to animal or human source, or country of origin.  These points can be addressed by sourcing and qualifying materials based on an evaluation of potential risk and desired functional characteristics, and defining supplier requirements, testing, specifications, and other control mechanisms accordingly.  Raw material qualification becomes increasingly rigorous and comprehensive as clinical development progresses.  This webinar will identify critical concerns, clarify regulatory requirements and outline how to develop robust systems for managing and qualifying raw materials.

Presented by Scott R. Burger, MD, Principal of Advanced Cell & Gene Therapy, LLC

Scott R. Burger, MD, is the Principal of Advanced Cell and Gene Therapy, a consulting firm specializing in cell and gene therapy product development, manufacturing, and regulatory affairs. Dr. Burger has over 25 years of experience developing cell and gene therapy products and has consulted for over 100 industry and academic clients in North America, Europe, Asia, and Australia. He has directed or consulted on process development, manufacturing, and regulatory aspects of a wide range of cell therapy and gene therapy products, including CAR T-cells, gene-edited cells, dendritic cell vaccines, natural killer (NK) cells, and other immunotherapies, hematopoietic stem cells (HSCs) from bone marrow, blood, umbilical cord blood, and regenerative medicine products such as mesenchymal stem cells (MSCs), chondrocytes, pancreatic islet cells, and other somatic cell therapies.

Dr. Burger’s regulatory background includes numerous IND and IDE submissions and productive interactions with FDA-CBER Office of Tissues and Advanced Therapies (OTAT, formerly the Office of Cellular, Tissue and Gene Therapies, OCTGT). Dr. Burger is a member of several scientific advisory boards, and has served on the USP Cell, Gene and Tissue Therapies Expert Committee, the ISCT advisory board and ISCT committees on gene therapy, regulatory affairs, commercialization, and product/process development. A graduate of the University of Pennsylvania School of Medicine, Dr. Burger completed training in clinical pathology and transfusion medicine at Washington University in St. Louis. Prior to founding Advanced Cell & Gene Therapy in 2002, Dr. Burger was Vice-President for R&D at Merix Bioscience, and director of the University of Minnesota Cell Therapy Clinical Laboratory. Dr. Burger is author of over 200 scientific publications and presentations, and recipient of numerous honors and awards.


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