Rentschler Biopharma’s ATMP facility in Stevenage, UK, receives MHRA approval

2023-09-13

基因疗法临床研究

UK site now set for clinical production of adeno-associated virus (AAV) vectors for gene therapy Highly experienced team ready to support ATMP innovators at all stages Offering comprehensive range of services from early process and analytical development through cGMP manufacturing for clinical trials STEVENAGE, United Kingdom and LAUPHEIM, Germany, Sept. 13, 2023 (GLOBE NEWSWIRE) -- Rentschler Biopharma SE, a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals, including advanced therapy medicinal products (ATMPs), today announced that it has received the cGMP Manufacturing Compliance Certificate, following the successful inspection by the UK Medicines & Healthcare Products Regulatory Agency (MHRA) at its UK site. The ATMP business was announced in early 2021 and the facility is located in the Cell and Gene Therapy Catapult’s Manufacturing Innovation Centre in Stevenage. Dr. Robert Panting, General Manager of Rentschler Biopharma’s ATMP business, said: “MHRA’s approval marks a major milestone for Rentschler Biopharma, and we are excited to offer our services from process and analytical development through cGMP manufacturing. Our team is highly knowledgeable, bringing years of experience in the field of AAV. We provide a tailored program for each client, in line with their needs and stage of development, while working closely with them to move projects forward as rapidly as possible. We are thus continuing the Rentschler tradition of offering a truly client-centric approach with the ultimate goal of helping patients. With our first clients already on board, we look forward to adding other exciting programs soon.” Dr. Christian Schetter, Chief Scientific Officer of Rentschler Biopharma, commented: “Our contribution to improving the health and quality of life of seriously ill patients is made possible by continuously expanding our expertise in the production of life-saving biopharmaceuticals. By launching Rentschler’s ATMP business, we aim to address an important gap in expertise and support for innovative, early-stage cell and gene therapy programs. It is gratifying to achieve this important milestone of MHRA approval, bringing us closer to reaching our objective of supporting clients already from the earliest stages of CMC development. We are continually looking to understand not only current client needs but future ones as well, which is how our ATMP offering came to fruition. We will continue to listen to our clients to anticipate how we can improve our offering and collaborate in advancing medicine to save lives, together.” Following the successful MHRA inspection, Rentschler Biopharma’s ATMP business can now offer its full range of services for the clinical supply of AAV, including bioprocess and analytical development through to cGMP manufacturing at their Stevenage facility in the UK. The company works to be a true partner to entrepreneurial players to enable them to transform their ideas into real products with the potential to treat and even cure patients with serious and life-threatening diseases. About Rentschler Biopharma SE Rentschler Biopharma is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. The company offers process development and manufacturing of biopharmaceuticals, including adeno-associated virus (AAV) gene therapies, as well as related consulting activities, project management and regulatory support. Rentschler Biopharma's high quality is proven by its long-standing experience and excellence as a solution partner for its clients. A high-level quality management system, a well-established operational excellence philosophy and advanced technologies ensure product quality and productivity at each development and manufacturing step. Rentschler Biopharma is a family-owned company with about 1,200 employees, headquartered in Laupheim, Germany, with a second site in Milford, MA, USA. Rentschler ATMP Ltd., located in Stevenage, UK, is dedicated to cell and gene therapies. For further information, please visit . Follow Rentschler Biopharma on LinkedIn and Facebook. Contact: Rentschler Biopharma SE Dr. Latika Bhonsle-Deeng Senior Director Corporate Communication Phone: +49-7392-701-874 communications@rentschler-biopharma.com Media inquiries: MC Services AG Eva Bauer Phone: +49-89-210228-0 rentschler@mc-services.eu U.S. Laurie Doyle Phone: +1-339-832-0752