Rentschler Biopharma SE, a global contract development and manufacturing organization (CDMO) for biopharmaceuticals, 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.

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.

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.”

Christian Schetter, chief scientific officer of Rentschler Biopharma, said, “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.”