Pharma Focus Europe

MHRA Grants Approval to Rentschler Biopharma's Advanced Therapy Medicinal Product (ATMP) Facility in Stevenage, UK

Thursday, September 14, 2023

Rentschler Biopharma SE, a leading global contract development and manufacturing organization (CDMO) specializing in biopharmaceuticals, including advanced therapy medicinal products (ATMPs), has announced the receipt of the cGMP Manufacturing Compliance Certificate. This achievement comes following a successful inspection by the UK Medicines & Healthcare Products Regulatory Agency (MHRA) at its UK facility, situated within the Cell and Gene Therapy Catapult’s Manufacturing Innovation Centre in Stevenage.

Dr. Robert Panting, General Manager of Rentschler Biopharma’s ATMP business, expressed excitement about this milestone, stating, "MHRA’s approval represents a significant achievement for Rentschler Biopharma. We are delighted to offer a full suite of services, encompassing process and analytical development through to cGMP manufacturing. Our team boasts extensive expertise in the AAV field and is committed to tailoring programs to the specific needs and developmental stages of our clients. We work closely with them to accelerate project progress, upholding Rentschler's tradition of delivering a truly client-centric approach with the ultimate goal of benefiting patients. With our initial clients already on board, we eagerly anticipate the addition of other exciting programs soon."

Dr. Christian Schetter, Chief Scientific Officer of Rentschler Biopharma, added, "Our mission to enhance the health and well-being of seriously ill patients relies on our continuous expansion of expertise in the production of life-saving biopharmaceuticals. Through the launch of Rentschler's ATMP business, we aim to address a crucial gap in expertise and support for innovative, early-stage cell and gene therapy initiatives. Obtaining MHRA approval is a gratifying milestone that brings us closer to our objective of aiding clients from the earliest stages of CMC development. We are committed to not only meeting current client requirements but also anticipating future ones. This is precisely how our ATMP offering came to fruition. We remain dedicated to listening to our clients and proactively enhancing our offerings, all in the spirit of advancing medicine to save lives."

Following the successful MHRA inspection, Rentschler Biopharma’s ATMP business is now fully equipped to provide a comprehensive range of services for the clinical supply of AAV, including bioprocess and analytical development, culminating in cGMP manufacturing at their facility in Stevenage, UK. The company operates as a true partner to entrepreneurial entities, empowering them to turn their concepts into tangible products with the potential to treat and even cure patients grappling with severe and life-threatening diseases.

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