The firm will provide its full array of viral vector services from the Great Ormond Street Hospital (GOSH).
July 24, 2024
Contract development and manufacturing organization (CDMO) ViroCell Biologics announced the signing of a master services agreement (MSA) with a National Cancer Institute (NCI)-designated cancer center.
The signing follows ViroCell’s successful GMP manufacture of a lentivirus vector used by the cancer center to clinically evaluate a novel engineered T-cell receptor (TCR) therapy for treating a variety of cancers.
The five-year deal grants the center access to ViroCell’s full range of preclinical and clinical viral vector services to accelerate its clinical development of novel gene-modified cell therapies. The firm’s clinical services include global plasmid sourcing, GMP manufacturing, expedited quality control release testing, regulatory filing support, and in-house qualified person batch review and approval for export and use in global clinical trials.
“We are delighted to have signed this MSA with one of the world’s premier cancer research centers,” said John Hadden, CEO of ViroCell Biologics. “It further underscores our ability to provide highly specialized GMP viral vector manufacturing services to cutting-edge research groups both in academia and industry as they translate their science into next-generation cell and gene therapies.”
A spokesperson for ViroCell Biologics told BioProcess Insider that the company’s manufacturing facility is located within GOSH’s state-of-the-art GMP cleanroom facility, the Zayed Centre for Research in London, UK. The facility is 6,400 square feet and has been inspected by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
GOSH provides services to children with rare cancers and genetic disorders. According to its website, the hospital sees about 76,000 children annually.
The ViroCell spokesperson said that the “agreement follows the successful GMP manufacturing and expedited release of a unique lentivirus vector for a novel cell therapy trial being run by the cancer center.” He added the agreement will enable “ViroCell to provide viral vector design and GMP manufacturing support for this institution's prolific team of physician scientists as they launch novel cell therapies to potentially treat a broad range of malignancies.”
Before it was licensed for GMP manufacturing, the spokesperson said that the company invested in systems and equipment so that it could meet client needs at scale. And before it received MHRA approval in November 2023, the company prepared by training multiple teams in delivering quality GMP vector batches at pace. “We had a sense of the gap in the market and the likely magnitude of client demand,” the spokesperson explained.
The financial details and distribution timelines of the agreement were not disclosed.
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