UK ATMP facility granted cGMP approval
A UK CDMO is now permitted through MHRA certification to produce clinical supply of gene therapy AAV, including bioprocess through to cGMP manufacturing.
Following a UK Medicines & Healthcare Products Regulatory Agency (MHRA) inspection, Rentschler Biopharma SE’s UK advanced therapy medicinal products (ATMP) facility has received a current good manufacturing practice (cGMP) Manufacturing Compliance Certificate. This means that the contract development and manufacturing organisation (CDMO)’s site in the Cell and Gene Therapy Catapult’s Manufacturing Innovation Centre in Stevenage, is compliant to produce adeno-associated virus (AAV) vectors for gene therapy.
Following the successful MHRA inspection, the CDMO can offer its full range of services for the clinical supply of AAV, including bioprocess and analytical development through to cGMP manufacturing.
“MHRA’s approval marks a major milestone for Rentschler Biopharma,” commented Dr Robert Panting, General Manager of Rentschler Biopharma’s ATMP business.
AAV vectors for gene therapies
Last month, Rentschler Biopharma agreed to join a collaboration with CGT Catapult to improve the process and efficiency of gene therapy AAV production. The two-year project was reported to utilise automated and digital process analytical technologies (PAT).
Upon announcement of the collaboration, Dr Christian Schetter, Chief Scientific Officer of Rentschler Biopharma declared that the project would ultimately help to lower the risk associated with the transition from early to late-stage manufacturing. The work is being funded by Innovate UK, via a ‘Digitalisation and automation of medicines R&D and manufacture’ grant.
