Adjunct Faculty Philadelphia College of Pharmacy and Science Coatesville, Pennsylvania
Chemistry, Manufacturing, and Control (CMC) readiness is a key challenge in the expedited development of cell therapy products. The preference for off-the-shelf allogeneic products is still present, but autologous products (cryopreserved) are still being developed. Current and innovative cell therapy manufacturing platforms and manufacturing facility considerations including centralized, decentralized, and near-patient manufacturing will be presented. Chain of custody protocols must be followed, and transporting and delivering cell therapy products to patients remains a big challenge. The FDA and the cell therapy product manufacturer should develop an agreement on sustainable quality standards for manufacturing control strategies for each product class. Points to consider from marketed cell therapy products and regulatory guidance documents will be discussed.
Learning Objectives:
Understand the cell therapy product quality attributes that impact the manufacturing controls
Recognize cell therapy product manufacturing will evolve based on product-dependent attributes
Discuss the critical Chemistry, Manufacturing and Controls (CMC) issues for cell therapy product development
