PharmaIndustrial India Magazine September-October 2023

Bayer Invests 250 Million USD in New Cell Therapy Manufacturing Facility in the US Biocon Biologics Receives Complete Response Letter from US FDA for Biosimilar Insulin Aspart Bayer AG has opened a new cell ther- apy production plant in Berkeley, Cali- fornia, USA, to bring cell therapies to patients on a global scale. The USD 250 million investment will support the pro- duction of material required for clinical trials and potential commercial launch of BlueRock Therapeutics’ bemdane- procel (BRT-DA01), an investigational cell therapy currently in evaluation for treating Parkinson’s Disease. BlueRock Therapeutics LP is a clinical stage cell therapy company and wholly owned, independently operated subsidiary of Bayer AG. The new facility will also sup- port the future production of additional cell therapies as Bayer’s cell therapy portfolio advances. “This new facility ensures our investment in cell therapies can become a reality for patients around the world,” said Stefan Oelrich, member of the Board of Man- agement of Bayer AG and President of the company’s Pharmaceuticals Divi- sion. “Cell therapies represent an im- portant opportunity to treat diseases differently by targeting the underlying cause or enabling the human body to restore vital functions.” The new cell therapy facility is part of a transformation at the company’s ded- icated biotechnology site in Berkeley, California, where Bayer has invested around USD 500 million over the past five years. “Manufacturing is an important element in taking the biopharmaceutical sec- tor’s pipeline of cell and gene therapies from the laboratory to patients, and this facility enables Bayer to play a critical role in making that happen,” said Hol- ger Weintritt, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of Product Supply of the Pharmaceuticals Division of Bayer AG. “We’re building on our capabilities in manufacturing the most complex pro- tein therapeutics to drive forward plat- forms that further enable the industry to bring these new medicines to patients worldwide.” Bayer’s global biotech organization supports pharmaceutical innovators to transfer their product candidates from the laboratory bench to patient care. The company’s biotech team provides its biologic development and manufac- turing capabilities for Bayer’s larger bio- therapeutics portfolio, including com- mercial products and late-stage protein and cell therapies in development. At the same time the company supports third party companies to enable patient trials and commercial launches through its BioPartnering Solutions offerings. The U.S. Food and Drug Administration (US FDA) has issued a Complete Re- sponse Letter (CRL) for the Biologics License Application (BLA) for Insulin Aspart. The CRL did not identify any outstanding scientific issues with the product. The CRL references the re- quirement for a satisfactory resolution of deficiencies from the pre-approval in - spection (PAI) of its Malaysia facility for Insulin Aspart, held in August 2022. The Company had submitted a com- prehensive Corrective and Preventive Action (CAPA) plan in September 2022, that the agency found to be adequate and indicated that it would require a re-inspection of the Malaysia facility, pri- or to the approval of the application. In February 2023, the Company sub- mitted a report from an independent third-party consultant, providing evi- dence of CAPA completion and effec- tiveness. However, the PAI reinspection was not scheduled prior to the goal date of October 6, 2023. “The Company will continue to engage with the US FDA for an expeditious res- olution and approval of its biosimilar In- sulin Aspart application. This decision has no impact on the manufacturing or distribution of the Company’s existing commercial portfolio. Biocon Biologics is committed to bringing high-quality and affordable medicines to the United States,” said the Company Spokesper- son. PHARMA INDUSTRIALINDIA · SEP-OCT 23 09 NEWS