Despite the promise of cell therapies, manufacturing the personalized medicines at scale has been a limiting factor for many companies. Now, as BlueRock Therapeutics advances its lead prospect, its parent company Bayer is ready to kick production into high gear.
Bayer on Tuesday opened its first Cell Therapy Launch Facility in Berkeley, California, which is expected to create capacity to bring cell therapies to patients worldwide.
Bayer has invested $250 million to build the plant, which will initially crank out materials for late-stage clinical trials across 100,000 square feet of space, the drugmaker said in a release.
The plant is also equipped to support the potential commercial launch of BlueRock’s experimental cell therapy for Parkinson’s disease, bemdaneprocel.
At the moment, BlueRock says planning is underway for its phase 2 study of bemdaneprocel, which is expected to start enrolling patients in the first half of 2024.
The plant features flexible, modular space for cell culture, viral transduction and automated filling of cell therapies, Bayer said.
Already eyeing future expansions, Bayer says the facility includes space for a second module of production suites to support additional cell therapies as the company’s portfolio advances.
The launch facility comprises part of a transformation at Bayer’s dedicated biotechnology site in Berkeley, where the company has invested nearly $500 million in infrastructure over the past five years.
Meanwhile, several other cell therapy facilities have started to take flight in 2023.
Last month, Novo Nordisk’s owner, the Novo Nordisk Foundation, said it was investing about $136 million into a new clinical production site at the Technical University of Denmark in Lyngby.
Dubbed the Cellerator, the facility will cater to public and private clients in academia, biotech and the pharmaceutical industry. Construction is due to kick off next summer, and the site is expected to be operational in 2027, the Novo Nordisk Foundation said in a release.
The center is being established to bridge a "critical gap" in the current cell therapy ecosystem, Thomas H.R. Carlsen, CEO of the Cellerator, said in an interview.
Meanwhile, in June, the U.S. FDA signed off on commercial cell therapy manufacturing at Bristol Myers Squibb’s sprawling facility in Devens, Massachusetts.
The cell therapy portion of the Devens site includes 244,000 square feet and has been under construction since 2021. It’s now BMS’ third commercial CAR-T manufacturing facility in the U.S.