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.”
About ViroCell:
ViroCell Biologics is an innovation-driven Contract Development and Manufacturing Organization (“CDMO”) focused exclusively on the design, derisking, and GMP manufacture of viral vectors for clinical trials. Built around one of the most prolific academic viral vector manufacturing teams, ViroCell was created to address the global demand for precisely engineered viral vectors and aims to become the partner of choice for companies developing cell and gene therapies. The team leverages its deep track record to help clients to de-risk and accelerate novel cell and gene therapies into and through clinical development, with a mission of being the partner of choice for corporate and academic innovators in this field. Focused initially on manufacturing lentivirus and gamma-retrovirus vectors, ViroCell enables clients to start clinical trials on a scalable platform, delivering value by reducing costs, time and regulatory risk.
For more information please visit, www.virocell.com
