Characterizaton and Validation 2023

Simplifying residual DNA quantitation and biotherapeutic manufacturing

Cell & Gene Therapy Insights 2023; 9(11), 1457–1464

DOI: 10.18609/cgti.2023.190

Published: 13 December 2023
Innovator Insight
Ilaria Scarfone

Meeting regulatory guidelines for any biologic depends on robust product characterization, and cell and gene therapies are no exception. The analytical data must prove the safety, efficacy, purity, quality, and potency of the final drug product. A key consideration for the product characterization process is choosing between an in-house developed assay solution or a commercial kit for quantitating residual DNA within a bioproduction workflow. This article will explore the challenges in the development of residual DNA assays and presents a comprehensive commercial solution to help save time and cost in the development process.