The agreement will cover technology transfer, scale-up, and validation of the manufacturing process for TNFerade through cGMP consistency lots that will be produced at Cobra’s facility in Oxford, United Kingdom.
“GenVec selected Cobra based upon their expertise in viral manufacturing and the experience of key staff members with commercial biopharmaceutical products. Activities under this agreement will establish a clear path for the submission of the chemistry, manufacturing, and controls (CMC) portion of a biological license application for TNFerade as GenVec works towards the completion of our current Phase III clinical trial,” said Dr. Bryan Butman, GenVec’s Senior Vice President of Vector Operations.
“We are delighted to work with GenVec on this exciting project. TNFerade has demonstrated great potential for the treatment of pancreatic cancer,” added Simon Saxby, Cobra Biomanufacturing’s Chief Operating Officer. “This agreement will leverage Cobra’s significant experience manufacturing recombinant adenovirus under cGMP conditions.”