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: Regulatory
Data Integrity is not a new issue; indeed, it has been part of WHO, FDA and MHRA guidelines for many years. However, recently, the major regulatory agencies have sought to reinforce the importance of Data Integrity (DI), issuing further guidance and auditing accordingly. It is not just an “India and China” issue where most FDA… Read more »