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: Tech Transfer
Using experience gained managing the global transfer of over 20,000 products, Verta helps clients ensure the successful technology transfer of production to new supply sites globally. We do this by building a fully integrated project plan, which takes you through a proven 10 step process (see diagram below) that identifies the activities and resources required… Read more »