ViroCell Biologics, a specialist CDMO for cell and gene therapy (CGT) clinical trials, 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 Authorization 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. With ViroCell now able to leverage GOSH’s 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.

The Zayed Centre for Research was established in 2019 and is a 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 Hadden, CEO at ViroCell, said, “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 catalyze 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.”

Claire Booth, Mahboubian professor in gene therapy and pediatric immunology at GOSH and UCL GOS ICH, and clinical academic lead for the cell & gene therapy service at GOSH, said, “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.”