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.

Operational Support: Allowing Companies to focus on what they do best

Posted by & filed under Operational Support.

Verta Life Sciences is an International Consulting and Product Management company that supports Life Science Companies, Develop, Manufacture, Register, Launch and Manage the Supply of their Products. We have been helping clients launch and supply products into the US Market for over 10 years. There are a growing number of smaller companies specializing in discovery… Read more »