The analytical methods handoff is pivotal to the overall success of a manufacturing process transfer from one location to another, and multiple pitfalls lurk, Biologics Consulting Group’s Christina Vessely cautioned at the 2015 Latin America CMC Strategy Forum organized by CASSS in Brasilia, Brazil in late August.
Vessely stressed that facility location transfers shed hard light on any weaknesses a manufacturer may have in understanding their analytical methods and manufacturing process and that these gaps can undermine the tech transfer, particularly given the analytical and process complexities in the biotech context.
The BCG consultant began her talk by highlighting the importance of establishing analytical comparability in relocating biotech manufacturing and advising on how firms can increase the probability of successfully dealing with the challenges involved.
She then explored the various problems that can and do surface in the analytics handoff in carrying out a process transfer plan – citing a case study of a transfer she was involved with from an internal site in Switzerland to an external CMO in the US. She concluded with a review of the key lessons learned.