PacificGMP and Vasgene Therapeutics have successfully completed the large-scale cGMP manufacture of Vasgene’s recombinant fusion protein for use in a Phase I trial. “Using our 500-liter capacity Wave bioreactor platform, we produced and subsequently purified enough of Vasgene’s recombinant fusion protein to aseptically fill more than 2,500 vials,” said Kristin DeFife, vice president of operations at PacificGMP. “We worked very closely with the scientists at Vasgene and welcomed their person-in-plant to ensure the success of this important project.”
 
“We selected PacificGMP as our CMO because of their considerable expertise in scale-up and cGMP manufacturing of proteins using single use technology as well as for their commitment to being a partner in our efforts to bring this product to the clinic. We are very pleased with PacificGMP’s manufacture of Vasgene’s recombinant fusion protein to support development of this cancer therapeutic agent,” said Parkash Gill, M.D., Vasgene’s co-founder and director.