ViroCell Biologics a cell and gene therapy (CGT) contract development and manufacturing organization (CDMO) specializing in GMP viral vector manufacturing for clinical trials, has signed a five-year Master Services Agreement (MSA) with a prominent U.S. NCI-designated cancer center.

Under the MSA, the cancer center will have access to ViroCell’s full range of pre-clinical and clinical viral vector services to accelerate its clinical development of novel gene-modified cell therapies. Pre-clinical services available include viral vector design, MicroBatch and pre-clinical batch manufacturing and process development. Clinical services include global plasmid sourcing, GMP manufacturing, expedited quality control release testing, regulatory filing support, and in-house Qualified Person (QP) batch review and approval for export and use in global clinical trials.

The signing of the MSA follows the successful GMP manufacture of a lentivirus vector by ViroCell for use by the cancer center in the clinical evaluation of a novel engineered T cell receptor (TCR) therapy, for the treatment of a variety of cancers. The vector was released to the cancer center for clinical use less than five months after the start of GMP manufacture.

John W. Hadden II, CEO at ViroCell, commented: “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.”