Biotech Drug Development in Record Time

Posted by & filed under Analytical, Biological Development, Industry Trends, New Product Registration & Launch, Operational Support, Quality, Regulatory, Supply Chain, Tech Transfer.

Verta Life Sciences

Verta Life Sciences has recently delivered a BLA-ready CMC package for a 4,000L mAb process for a client in record time. In just 2.5 years, we have scaled up from a Phase I 100L process, completed process characterization, validated the Drug Substance (DS) and the Drug Product (DP) processes as well as the analytical methods at the originator sites and transferred the product successfully to three (3) additional commercial DS sites (2 US, 1 in Asia). Verta has done this with a small, dedicated, relentless team.