There are many hurdles to streamlined, cost-effective manufacturing of cell and gene therapy products. To help address this, the Alliance for Regenerative Medicine published A-Cell, a case-based guidebook to help drug developers incorporate Quality by Design (QbD) principles into cell-based therapy CMC programs. A-Cell builds on previous QbD efforts that were applied to the manufacturing of monoclonal antibodies (A-Mab), vaccines (A-Vax), and more recently, gene therapies (A-Gene), bringing best practices in CMC to a case study of a CAR-T therapy manufacturing.

This is the second of a two-part deep dive into the A-Cell document as part of a round table conducted during Meeting on the Mesa. This episode covers key questions around conducting a risk assessment and best practices for product and process characterization for cell therapies.