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.
Posts Categorized: New Product Registration & Launch
Verta Life Sciences is an International Consulting and Product Management company that supports Life Science Companies, Develop, Register, Launch and Ensure the Supply of their Products. In the last two years alone we have helped clients develop, register and launch 5 New Products. We work with clients to ensure that their product’s; manufacturing processes are… Read more »