REGULATORY & OPERATIONAL CONSIDERATIONS WHEN SOURCING CELLULAR STARTING MATERIALS & ANCILLARY PRODUCTS FOR CELL THERAPY DEVELOPMENT & COMMERCIALIZATION
Important considerations should be taken in the selection of a manufacturer to source Leukocytes/Cellular starting materials and related ancillary products. Manufacturers must be GMP/GTP compliant and capable of sourcing RUO and GMP materials to allow an efficient path for ATMPs to move through the clinical pipeline and be approved for commercial use.
The FDA has promulgated a particular set of regulations, referred to as GTPs, that specifically address the need to procure and process tissues in a manner that avoids transmission of a communicable disease. GTPs and GMPs must be followed for cell-based advanced therapies or tissue-based therapy products.
Key takeaways:
- Why is it so important to have a dedicated supplier with recallable donors that is compliant with GTPs and GMPs?
- What are the costs and time delays of switching suppliers later in clinical development?
- Can a manufacturer of a cell or gene therapy switch suppliers midstream in clinical development?
- How will not having a GMP supplier impact the speed a therapy gets to market?
Hear from our team of experts as they share their unique insights on these important topics in a roundtable style discussion.
About the Presenters
Matthew Chorley, MS, MBA, is a seasoned professional with more than 27 years’ experience leading GMP quality assurance, quality control, validation, and manufacturing operations in cell and gene therapy, biologics, traditional pharma and related regulated industries, Matthew was appointed by BioIVT to oversee its global quality assurance and quality control organization in April 2022.
During his career, Matthew has started, built, and optimized best-in-class GMP quality organizations and quality management systems, and expanded and enhanced existing capabilities to help companies.
Parijat Jain, Ph.D., MBA, is a strategic professional with two decades of experience in the pharmaceutical brand, generics and Life Sciences/CDMO space, in the areas of business & general management, strategy, commercial, marketing, operations, clinical production and R&D across dosage form modalities and bioprocessing value chains.
In April 2023, he was appointed by BioIVT to oversee their fastest growing Cell & Gene Therapy Business Unit, leading the Donor Centers and Serum manufacturing facility. Prior to joining BioIVT, Parijat held roles at Lonza, Teva, and Novartis Pharmaceuticals.
During his career, Parijat published several scientific research articles and books, and launched multiple commercially marketed products. He has successfully established new business organizations, teams, strategies, processes, and has strongly driven revenue, profitability and growth for various companies.
Wini Luty, MS, is a scientist with over 20 years experience working in the life sciences and blood collection industry. Wini currently oversees the best-in-class CGT operations and donor center operations at BioIVT. She brings a wealth of knowledge in immunology, cell separations, donor collections, and operational experience to lead the operations team.