ViroCell and Great Ormond Street Hospital poised to unlock clinical trial ‘backlog’ following MHRA manufacturing approval

Wednesday, 8 November 2023

MHRA licence will enable global reach of ViroCell’s viral vectors for cell and gene therapy clinical trials. ViroCell’s manufacturing operations are housed within Great Ormond Street Hospital’s state-of-the-art GMP accredited unit for manufacturing cell and gene therapies, the Zayed Centre for Research.
Really pleased to share the MHRA approval of The Great Ormond Street Hospital for Children NHS Foundation Trust's viral vector manufacturing license.

The licensing announced today marks a key milestone for ViroCell in the global supply of precisely engineered viral vectors to GMP standards for Cell and Gene Therapy clinical trials, and I'm excited to see ViroCell’s next stage of growth as it supports the development of advanced therapies.
London, UK and New York, US, 1 November 2023 – ViroCell Biologics (“ViroCell” or the “Company”), a specialist contract development and manufacturing organisation (“CDMO”) for cell and gene therapy (CGT) clinical trials, announces that the Company is now able to manufacture and globally export viral vectors from Great Ormond Street Hospital’s (GOSH) state-of-the-art manufacturing facility, the Zayed Centre for Research, for use in clinical trials. This follows the grant of a Manufacturer’s Authorisation License (MIA) to GOSH to manufacture viral vectors by the UK’s Medicines and Healthcare products Regulatory Agency’s (MHRA).
Viral vectors are commonly used by CGT innovators to genetically modify human cells to create novel therapeutics. A lack of experienced capacity in viral vector supply, both in the UK and globally, has resulted in a shortage of lentivirus and gamma-retro viral vectors in the CGT market. This shortage in clinical trial vector supply is believed to be slowing the progress of bringing novel medicines to patients. With ViroCell now able to leverage GOSH's state-of-the-art manufacturing facility, the Company is poised to relieve the strain on clinical research caused by the vector shortage and expand the supply of precisely engineered viral vectors for clinical trials.
ViroCell believes the significance of the current vector constraint on CGT clinical research in the UK is reflected by the MHRA’s issuance of the MIA to GOSH to manufacture viral vectors, as it continues to position the UK as a hub for life science innovation. The MHRA is widely considered a gold-standard regulatory authority, with its rigorous requirement for facility inspection and licencing for advanced therapy manufacturing for clinical trials. Therefore, in addition to accelerating CGT clinical trials in the UK, this approval could also help accelerate the start of new clinical trials worldwide, as ViroCell ramps up the manufacturing of vectors for global export.
The Zayed Centre for Research was established in 2019 and is a state-of-the-art GMP accredited unit for manufacturing CGTs, with seven specialist clean rooms. The facility houses the latest technologies to support ViroCell's GMP manufacturing operations, creating a full-service model for the global supply of clinical grade viral vectors to researchers and industry alike.
John W. Hadden II, CEO at ViroCell, commented: “Addressing the global viral vector supply/demand imbalance is a top priority for Team ViroCell as the scarcity of high-quality viral vectors has constrained the ability of innovators to manufacture their novel cell and gene therapies. This approval is an exciting milestone for ViroCell and GOSH, which should catalyse our next phase of growth as we unlock ViroCell’s full potential as the partner of choice for cell and gene therapy companies demanding precision engineered viral vectors produced to GMP standards. We highly value the MHRA’s collaboration and look forward to strengthening our partnership with GOSH as we work to help accelerate clinical trials for advanced therapy patient candidates around the world."
Professor Claire Booth, Mahboubian Professor in gene therapy and paediatric immunology at GOSH and UCL GOS ICH, and Clinical Academic Lead for the Cell & Gene Therapy Service at GOSH, added: “We are delighted that GOSH has been granted MHRA licensing for the manufacture of viral vectors. With our state-of-the-art facility and ViroCell’s international network of collaborators, vectors for both UK and global projects can be manufactured at the Zayed Centre for Research, unclogging the industry-wide bottleneck, accelerating cell and gene therapy clinical trials and expanding the novel treatments that we can offer to our patients.”