The facility has been designed to accommodate a second module of production suites, which will play a crucial role in supporting future cell therapies within Bayer's expanding portfolio
The new will help produce transformational cell and gene therapies on a global scale. (Credit: Business Wire/ Bayer AG)
Bayer has opened its inaugural cell therapy launch facility located in Berkeley, California. This facility represents a pivotal step towards enabling the global distribution of cell therapies to patients.
With a substantial investment of $250m and spanning 100,000ft2, this facility is strategically positioned to provide the necessary materials for late-stage clinical trials and the potential commercial launch of BlueRock Therapeutics’ bemdaneprocel (BRT-DA01). This investigational cell therapy is currently undergoing evaluation as a potential treatment for Parkinson’s disease.
Furthermore, the facility has been designed to accommodate a second module of production suites, which will play a crucial role in supporting future cell therapies within Bayer’s expanding portfolio.
BlueRock Therapeutics, a clinical-stage cell therapy company, operates as a wholly owned and independently operated subsidiary of Bayer.
Bayer USA and Pharmaceuticals North America president and Pharmaceutical Executive Committee member Sebastian Guth said: “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.”
The newly established cell therapy launch facility is a significant component of the ongoing transformation at Bayer’s dedicated biotechnology site in Berkeley.
Over the course of the past five years, Bayer has committed substantial investments, totalling nearly $500 million, towards enhancing the infrastructure at this site.
BlueRock Therapeutics president and CEO Seth Ettenberg said: “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.
“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.”
The recently unveiled cell therapy launch facility, launched in tandem with Manufacturing Day in the US, represents just one of the many recent investments undertaken by Bayer to propel its biologic pipeline.
This pipeline encompasses a wide range of protein therapeutics, cell-based therapies, and gene therapies. Additional investments include the establishment of a new cell culture technology centre and cell therapy labs.
The cell therapy launch facility has been thoughtfully designed, offering flexible and modular spaces tailored for various activities such as cell culture, viral transduction, and automated filling of cell therapies.
Leveraging Bayer’s extensive expertise in Biotech, particularly in iPSC (induced pluripotent stem cell) and CAR-T (chimeric antigen receptor T-cell) characterisation, process development, analytics, and the transition from clinical to commercial production, this facility is poised to play a pivotal role in advancing new therapies.