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

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.

Please enter your email to access content Read now