MHRA Grants Rentschler Biopharma cGMP Compliance Certificate

After undergoing an inspection by the UK Medicines & Healthcare Products Regulatory Agency (MHRA), Rentschler Biopharma SE’s UK facility for advanced therapy medicinal products (ATMP) has been granted a Manufacturing Compliance Certificate in accordance with current good manufacturing practice (cGMP). This certification signifies that the contract development and manufacturing organization (CDMO) located within the Cell and Gene Therapy Catapult’s Manufacturing Innovation Centre in Stevenage is fully compliant and authorized to produce adeno-associated virus (AAV) vectors for gene therapy.

With the successful completion of the MHRA inspection, the CDMO is now equipped to provide its complete array of services for the clinical supply of AAV. This includes services ranging from bioprocess and analytical development to cGMP manufacturing.

Dr. Robert Panting, General Manager of Rentschler Biopharma’s ATMP business, expressed the significance of MHRA’s approval, considering it a pivotal achievement for Rentschler Biopharma.

In a related development, Rentschler Biopharma recently entered into a collaboration with CGT Catapult aimed at enhancing the efficiency and processes involved in gene therapy AAV production. This two-year initiative is expected to leverage automated and digital process analytical technologies (PAT). Dr. Christian Schetter, Chief Scientific Officer of Rentschler Biopharma, stated that this project’s ultimate goal is to mitigate risks associated with the transition from early-stage to late-stage manufacturing. The project is financially supported by Innovate UK through a grant focused on the digitalization and automation of medicines research and development and manufacturing.