AM24-MN-26-O: Overview of Cell-Based Biologics Manufacturing as a Contracted Service (Enduring)

CABP CE Eligible

Decentralized manufacturing has become a prominent focus in the Advanced Therapies space as the number of therapies in development increases and patient volumes surge with earlier line treatment objectives. Therapeutic developers are balancing risks and benefits of having a network of manufacturers executing more stable processes while a highly complex logistics supply chain develops and stabilizes. One approach to decentralized manufacturing leverages a network of regional “contract manufacturing organizations” which resembles the regionalized coverage of our blood center networks. Are blood centers the solution to decentralized manufacturing? Are blood centers interested in understanding the concept, scope, and scale of biologic therapeutic drug product manufacturing? This panel presented session will feature a broad overview of cell-based biologic product lifecycle and how each new product is integrated into a manufacturing facility including: Business practices of selecting and contracting with a manufacturing organization; Donor selection, testing and receipt of starting materials (autologous or allogeneic); Technology transfer of processes, materials, assays and specifications; cGMP readiness for biologics manufacturing; Operational and facility requirements for manufacture of biologic therapeutics; In-process quality control and release assays; and Batch review and release of cell-based biologics, with a special focus on potency assays. Our panel discussion will expand on these topics to include additional quality and regulatory focused phase-appropriate project campaigns necessary as products approach late-phase clinical trials and plan for commercialization such as: Assay qualification and validation, Raw materials testing and Process characterization.