Overcoming Obstacles in Viral-Vector Manufacturing: How To Design and Launch a Successful Program for Clinical-Trial Manufacturing

Experience with manufacturing viral vectors used for gene therapeutics is essential to mitigating risks in manufacturing of clinical trial materials. Collaborating with an experienced contract development and manufacturing organization (CDMO) with can help product developers design seamless and scalable vector-production processes. As authors from IDT Biologika describe here, a proven manufacturing platform and high-throughput analytical technologies help to ensure patient safety with products that meet high quality standards. The authors highlight the utility of digital polymerase chain reaction (dPCR), anion-exchange high-performance liquid chromatography (AEX-HPLC), size-exclusion chromatography with multiangle light-scattering (SEC-MALS), and next-generation sequencing (NGS) in gene therapy development.

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