BMS is building up its cell manufacturing footprint and network across the globe. The American pharmaceutical company currently has cell therapy manufacturing facilities in the US: including in Bothwell, WA and Summit, NJ. Last month BMS announced the addition of a new facility in Devens, MA; which has been followed by today’s announcement of the Leiden facility.
Further afield, BMS also has external manufacturing partners in the EU and Japan.
Manufacturing cell therapies is both operationally and technically complex because they are manufactured uniquely for each individual patient, using a patient’s own T cells as the starting material.
Leiden: entry into Europe
The Leiden site has been chosen thanks to the growing activity in life science in the region - and in particular the Leiden Bio Science Park where it will be located - and convenient access to transportation for shipping patient cells.
The site will manufacture and develop CAR T-cell therapy for patients with leukaemia.
The 19,000m2 facility will be commercially focused with capabilities for multi-product cell therapy manufacturing and the ability to scale up capacity.
Planning for the site design and development is now underway, with BMS promising it will leverage innovative technologies, the latest manufacturing equipment and advanced digital systems. Construction of the site is set to begin later this year, with site completion set for 2024.
The BMS facility is expected to bring 500 new jobs to the region.
Cell therapy portfolio: latest developments
BMS' cell therapy portfolio contains two approved therapies; and three investigational cell therapies in clinical trials. There is also a growing portfolio of early R&D treatments.
In March, The US FDA approved Bristol Myers Squibb and bluebird bio’s Abecma (idecabtagene vicleucel), the First Anti-BCMA CAR T Cell Therapy for Relapsed or Refractory Multiple Myeloma.
The same month, Japan's Ministry of Health, Labour and Welfare approved Breyanzi (lisocabtagene maraleucel: liso-cel); a CAR T cell therapy for relapsed or refractory large B-cell lymphoma and follicular lymphoma. (An external manufacturing parter carries out the early steps of the Breyanzi manufacturing process in Japan; while the latter steps are carried out at BMS' Bothwell facility).
Devens: state-of-the-art campus
The 244,000 square foot site will also be equipped to ramp up capacity for clinical and commercial cell therapy products.
BMS says it is embracing automation, digitalization and next-generation manufacturing technology to prepare for commercializing cell therapies.
“As construction progresses at the new Devens site, BMS is outfitting the facility to use the latest manufacturing technologies, including next generation manufacturing systems,” a spokesperson told BioPharma-Reporter. “We will also be using virtual reality programs for training new cell processing associates.
"Leveraging digitization efforts include implementation of electronic batch records. From an automation standpoint, we will leverage automated bioreactors and automated cartridge based flow cytometers.
“As a whole, BMS continues to leverage the latest technologies and approaches for greater efficiencies in the manufacturing process.”
With the new site situated on BMS’ existing 89 acre Devens campus for biologics, it will also offer accelerated career development for employees across biologics and cell therapies on a single campus. The company also hopes to hire several hundred employees over the next few years to support the new operations.
Construction of the Devens facility will be completed by the end of the year: while operational start-up for clinical manufacturing will begin in 2022 with the site ready for commercial manufacturing in late 2022 or early 2023.