Janssen Supplement Approved for Batch to Continuous Manufacturing

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] Seen as a “significant step towards integrating continuous manufacturing into pharmaceutical production,” FDA approved, for the first time, a request to change a facility’s production from batch to continuous manufacturing in early April. The approved change is for HIV-1 treatment Prezista, made by Janssen Pharmaceuticals. At the May GPhA CMC Workshop, OPQ Emerging Technology Team Chair Larry Lee noted that the supplement was approved a week before the user fee deadline, reflecting the support of the team for these technology advancements. CDER approved an NDA for Vertex’s oral solid Orkamb using continu- ous manufacturing in July 2015. [See IPQ Feburary/March 2106 Monthly Update for a review of how CDER is supporting contin- uous manufacturing as part of its effort to advance the use of emerging technologies.]
[/membership]