India Pharma Outlook Team | Tuesday, 23 July 2024
ViroCell Biologics, a company focused on cell and gene therapy contract development and manufacturing, has signed a five-year agreement with a leading U.S. cancer center for GMP viral vector manufacturing for clinical trials.
The cancer center will be able to utilize ViroCell's complete pre-clinical and clinical viral vector services under the MSA to speed up the clinical advancement of new gene-modified cell therapies. Available pre-clinical services include design of viral vectors, MicroBatch©, manufacturing of pre-clinical batches, and process development. Clinical services consist of worldwide plasmid procurement, GMP production, accelerated quality control testing for release, assistance with regulatory filings, and internal reviews by a Qualified Person (QP) for exporting and utilizing in international clinical trials.
ViroCell successfully manufactured a lentivirus vector for the cancer center's clinical evaluation of a new TCR therapy for various cancers, leading to the signing of the MSA. The vector was approved for clinical use at the cancer center within five months of beginning GMP production.
"We are delighted to have signed this Master Services Agreement with one of the world’s premier cancer research centers. It further underscores our ability to provide highly specialised 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. We look forward to working closely with the scientists at this prestigious institution, as they commence exciting new cancer drug development programs."