Bristol Myers scales up cell therapy production with liso-cel nod in hand and another approval maybe on the way
After a long-awaited approval for its CD19 targeting CAR-T liso-cel, Bristol Myers Squibb is gearing up for the looming review of another cell therapy in its pipeline, ide-cel. Taking not one but two CAR-Ts to market — and potentially more — means Bristol will have to step on the gas to get its manufacturing in order.
Looking to address that potential roadblock, Bristol will add a 244,000 square-foot cell therapy manufacturing facility at its Devens, MA site as it looks to grow its production capacity around liso-cel and, potentially, ide-cel in the coming weeks, the drugmaker said Tuesday.
The 89-acre Devens site in the Boston area will hold the fourth in-house cell therapy manufacturing site for Bristol, alongside facilities in Bothell, WA; and Warren and Summit, NJ. Bristol also counts contract partners in the EU and Japan as part of its cell therapy network.
The site will produce both clinical- and commercial-stage therapies, and Bristol expects to hire “several hundred employees over the next few years” to scale up the site, according to a release.
The financial terms of the expansion were not disclosed, and a Bristol spokeswoman did not comment by press time.
The expansion comes at an opportune time for Bristol as it looks to take CD19 targeted liso-cel, marketed as Breyanzi and approved earlier this month, to market. The therapy had a circuitous road to its FDA nod, including a series of manufacturing snafus at a Lonza Houston contract site that led to a Form 483 in December and may have torpedoed a $9 CVR from Bristol’s Celgene buyout tied, in part, to liso-cel’s approval by the end of 2020.
Meanwhile, Bristol is gearing back up for the FDA’s review next month of ide-cel, a BCMA CAR-T. Just weeks out from a potential decision, Bristol announced two weeks ago that it was pulling another CAR-T candidate in the pipeline, orva-cel, out of development and writing off $470 million from its books.
Samit Hirawat, head of drug development, explained in an analyst call this month that the decision was all about taking the best medicines forward — especially in a landscape as crowded as BCMA, where an autologous CAR-T doesn’t just have to face direct rivals like Legend’s J&J-partnered cilta-cel but also angle for space among off-the-shelf cell therapies, bispecifics, antibody-drug conjugates and more.