MHRA greenlights Rentschler CGT plant

Following an MHRA approval, Rentschler Biopharma’s site in Stevenage, UK is set for clinical production of AAV vectors for gene therapies.

The family-owned contract development manufacturing organization (CDMO) Rentschler Biopharma announced its plans in February 2021 to set up production capabilities at the UK’s Cell and Gene Therapy (CGT) Catapult in Stevenage, launching itself into the regenerative medicine space.

After a successful inspection by the UK Medicines and Healthcare Products Regulatory Agency (MHRA), the site has received the cGMP Manufacturing Compliance Certificate and is ready for clinical production of adeno-associated virus (AAV) vectors for gene therapies. The plant offers various services, ranging from early process and analytical advancement, through to cGMP manufacturing for clinical trials.

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“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,” Robert Panting, general manager of Rentschler Biopharma’s ATMP business, said.

“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.”

The CDMO said it aims to partner with different players in the space to transform their ideas into products. In June, Rentschler announced its Stevenage site will be used to support the bioprocess advancement of AAV material for pre-clinical testing of Ikarovec’s gene therapy treatment for geographic atrophy.