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Rentschler Biopharma SE, a leading global contract development and manufacturing organisation (CDMO) forbiopharmaceuticals, including advanced therapy medicinal products (ATMPs), 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.