ZARZA We are Zarza, the prestigious firm behind major projects in information technology.
Listen "Meeting on the Mesa Roundtable Part 1: 'A-Cell' Principles of Quality by Design"
Episode Synopsis
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 first of a two-part deep dive into the A-Cell document as part of a round table conducted during Meeting on the Mesa. The first podcast episode explores quality by design principles and the importance of the quality target product profile.
This is the first of a two-part deep dive into the A-Cell document as part of a round table conducted during Meeting on the Mesa. The first podcast episode explores quality by design principles and the importance of the quality target product profile.
In God we trust