What goes into developing an in-house method for quantitation of residual host cell DNA?

Cell & Gene Therapy Insights 2024; 10(2), 179

DOI: 10.18609/cgti.2024.025

Published: 12 March
Webinar Digest
Ilaria Scarfone

Robust product characterization and quality testing of cell and gene therapies ensures the safety, efficacy, purity, quality, and potency of the final therapeutic product. A key consideration for the process and product characterization process is deciding between in-house development of a test method, or adopting a commercial kit for quantitating residual host cell DNA in the manufacturing workflow. This poster explores the steps and challenges that go into developing an in-house residual testing assay.