ViroCell and Great Ormand Street Hospital receive MHRA manufacturing approval
ViroCell Biologics has announced that it can now manufacture and export viral vectors from Great Ormand Street Hospital’s (GOSH) state-of-the-art manufacturing facility, the Zayed Centre for Research, for use in clinical trials.
This follows the Medicines and Healthcare products Regulatory Agency’s (MHRA) granting of a Manufacturer’s Authorisation Licence (MIA) to GOSH for its viral vectors. Following the recent shortage in lentivirus and gammaretro viral vector in the cell and gene therapy (CGT) market, ViroCell intends to use this new manufacturing plan to ‘relieve the strain on clinical research caused by the vector shortage and expand the
supply of precisely engineered viral vectors for clinical trials,’ according to the company’s press release.
John W Hadden II, ViroCell’s chief executive officer, 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.”