A high-yielding process for manufacturing clinical volumes of DNA vaccines and gene-based therapeutics is said to be scalable, from lab to clinical trials and final product manufacturing. The process has been implemented at the Waisman Clinical Biomanufacturing Facility at the University of Wisconsin-Madison, according to an announcement from WCBF and gene-based technology process and product developer Nature Technology Corp.
The process represents a starting point for the development of gene-based biologics. Its availability is intended to give biomanufacturing clients a cost-effective way to make pharmaceutical grade DNA, which will carry through from animal studies to licensed product, without significant process changes.
"Switching either upstream (fermentation) or downstream (purification) processes, during the transition from preclinical to clinical to licensed product, would raise some thorny regulatory issues regarding bio-equivalence," says John Keach, business development officer for Waisman, in an announcement. In a worst case scenario, Keach says it's sometimes necessary to redo costly clinical trials when changes are introduced to the manufacturing process after human trials have been completed, highlighting the need for continuity during development.
- read the announcement