GMP manufacturing of quality ancillary reagents for cell and gene therapy

Safety, quality, consistency and effectiveness are defining features of cell and gene therapy therapeutic products. Achieving these features requires controlled and reproducible manufacturing workflows supported by rigorous, traceable documentation and consistent high-quality ancillary materials.

Ancillary materials influence the eventual success and quality of the cell product; therefore, effective management and a deep understanding of the risks associated with the use of ancillary materials in the manufacturing of cell products are necessary.

While guidelines and frameworks to manage ancillary materials have been established, Jessie Ni, VP of Product Development, and Bob Schmidt, GMP Bioprocessing Quality Systems Director, will discuss a risk-based strategy to assess challenges associated with the use of these reagents in cell and gene therapy applications.