ViroCell Biologics has secured approval from the U.K.’s healthcare regulator to begin manufacturing and exporting the viral vector products it makes at a leading children's hospital.
The London- and New York-based CDMO was given the green light by the Medicines and Healthcare products Regulatory Agency (MHRA) to produce viral vectors from a manufacturing facility at the Zayed Centre for Research at the Great Ormond Street Hospital in London, the company said in a Nov. 1 press release.
Viral vectors are critical for cell and gene therapy developers who use them to genetically modify human cells to create new therapies. A lack of capacity for producing viral vectors was revealed during the COVID-19 pandemic as a result of a shortage of lentivirus and gamma-retro viral vectors.
“Addressing the global viral vector supply/demand imbalance is a top priority for ViroCell as the scarcity of high-quality viral vectors has constrained the ability of innovators to manufacture their novel cell and gene therapies,” ViroCell CEO John Hadden said in the release.
The regulatory approval is expected to help speed up the start of new global clinical trials worldwide as the company ramps up manufacturing at the site.
The MHRA has been on a mission to overhaul clinical trial regulations in a move to boost the U.K.’s image as a preferred location to hold studies. The agency recently established new guidelines focused on cutting the time by half that it takes to approve lower-risk clinical trials.