ViroCell tackles CGT bottleneck with MHRA approval

ViroCell said MHRA’s manufacturing approval will allow it to produce viral vectors at Great Ormond Street Hospital (GOSH) for CGT clinical trials.

Contract development manufacturing organization (CDMO) ViroCell Biologics said the viral vector manufacturing license granted by the Medicines and Healthcare products Regulatory Agency (MHRA) enables it to produce and globally distribute viral vectors for cell and gene therapy (CGT) clinical trial use from GOSH’s London facility, named the Zayed Center for Research.

“It allows ViroCell to satisfy global demand from clients. Experienced vector design services are in short supply, and this helps unlock the market. The UK is a preferred regulatory environment to manufacture in given its high standards,” a spokesperson for ViroCell told BioProcess Insider.

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ViroCell expects to export the clinical trial material to the US, Europe (EU), Israel, Japan, and South Korea. Additionally, the spokesperson said the manufacturing facility has “significant capacity” and the headcount will not be increased as the “team is in place.”

In September 2021, ViroCell partnered with GOSH to address the global viral vector manufacturing bottleneck for clinical trials. At the time, the CDMO said the collaboration will more than double the UK’s lentivirus vector production capacity for clinical trials in 2022. Additionally, the firm said the deal will secure its position as the first CDMO in the UK to deliver adeno-associated viruses (AAV) vectors to the CGT space.

“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,” John Hadden, CEO at ViroCell, said.

“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.”

Easing the ‘backlog’

Viral vectors are being used in CGTs as they are devoid of viral proteins, free from replication competent virus, and able to transduce non-dividing cells. However, according to ViroCell, a shortage of experienced capacity in the supply across the globe has led to a shortage of lentivirus and gamma-retro viral vectors in the market.

Therefore, with the MHRA manufacturing approval, ViroCell is able to use GOSH’s production facility to elevate the “backlog” and increase the supply of engineered viral vectors for clinical trial use.