Bayer AG recently announced the inauguration of its first Cell Therapy Launch or Manufacturing Facility (MFTG) in Berkeley, California to create a capacity to bring cell therapies to patients on a global scale.
Industry sources added that this USD$250 million, 100,000-square-foot facility will supply the material required for late-stage clinical trials and potential commercial launch of BlueRock Therapeutics’ bemdaneprocel (BRT-DA01), an investigational cell therapy currently in evaluation for treating Parkinson’s disease.
Industry sources additionally confirmed that this facility will comprise a space for a second module of production suites to support additional cell therapies as Bayer’s portfolio advances. BlueRock Therapeutics LP is a clinical-stage, cell therapy company and wholly owned, independently operated subsidiary of Bayer AG.
Sebastian Guth, President of Bayer U.S.A. and Pharmaceuticals North America, and member of the Pharmaceutical Executive Committee stated “Cell therapy represents a groundbreaking class of medicines and is an area where Bayer is making a significant investment to research potentially transformative treatment approaches for people with unmet medical needs. Our new cell therapy facility represents true innovation in product development and manufacturing in addition to contributing to Bayer’s sustainability goal as our first fully electric pharmaceutical manufacturing plant.”
“Our teams are driving innovation in late-stage development and manufacturing with a goal of bringing transformational cell and gene therapies to patients on a global scale, and this facility will enable us to make it real,” said Jens Vogel, Sr. Vice President and Global Head of Biotech for Bayer’s Pharmaceutical Division. “Bayer is collaborating with biotech innovators, academia, and equipment and automation suppliers to establish platforms that would help bring more therapies to patients faster.”
“Having access to this Cell Therapy Launch Facility is central to our goal to deliver impactful cell therapies from our pipeline to patients in need,” stated Seth Ettenberg, President & CEO of BlueRock Therapeutics. “Our team is excited to be working shoulder to shoulder with Bayer’s biotech scientists and manufacturing experts as we look to scale up manufacturing for our first investigational therapy, bemdaneprocel for Parkinson’s disease, as it advances through clinical trials.”
Industry sources also added that this latest Cell Therapy Launch Facility is part of a transformation at the company’s dedicated biotechnology site in Berkeley, where Bayer has invested nearly USD 500 million in infrastructure over the past five years.
Bayer’s global biotech organization recognizes the importance of helping innovators transfer their product candidates from the laboratory bench to the clinical study and commercial launch settings. The Biotech team provides its biologic development and manufacturing capabilities for Bayer’s larger biotherapeutics portfolio, including commercial products and late-stage protein and cell therapies in development.
As part of Bayer’s larger mission of “Health for All,” the company is now also helping early-stage U.S. and European companies to enable patient trials and commercial launches through its BioPartnering Solutions offerings. Beyond Berkeley, the company’s global biotech network includes biologic development, manufacturing science, industrialization, and advanced manufacturing engineering teams in Wuppertal and Leverkusen, Germany; and Basel, Switzerland; with a full complement of labs and clinical production suites.
The new Cell Therapy Launch Facility, launched in conjunction with manufacturing day in the United States, is among several recent investments to advance Bayer’s biologic pipeline of protein therapeutics, cell and gene therapies including a new Cell Culture Technology Center and Cell Therapy Labs. The new Cell Therapy Launch Facility features flexible, modular space for cell culture, viral transduction and automated filling of cell therapies leveraging Biotech@Bayer expertise in iPSC and CAR-T characterization, process development, analytics, and clinical to commercial production.
