By David Schmidt, Cytovance Biologics
Many pharmaceutical manufacturers require clarity on quality standards for the use of plasmid DNA (pDNA) as a reagent, or as the final active pharmaceutical ingredient (API). Organizations working on viral vector-based gene therapies use pDNA as an integral part of their production workflow. However, as pDNA can also be the final API in therapeutics such as DNA vaccines – and subsequently be in direct contact with patients – establishing efficient, cost-effective quality oversight is crucial to minimize risks while staying on budget.
At Cytovance, a CDMO specializing in rapid development and manufacture of large molecule APIs, many of our clients engage us to create a “GMP light” development framework that reduces overhead, while guaranteeing quality assurance. Although “GMP light” does not exist, the team at Cytovance has developed a compelling new service offering – Cytograde™ pDNA – to help our clients produce high-quality, affordable pDNA for any process and at any developmental stage. Cytovance Biologics integrates world-class processes and scalable single- or multi-use equipment to efficiently produce superior plasmids.