PacificGMP and Vasgene Therapeutics Announce Successful Manufacture of Recombinant Fusion Protein for Phase 1 Clinical Trial
SAN DIEGO, June 6, 2012 /PRNewswire/ — PacificGMP (San Diego, California), the leader in single-use bioprocessing for development and manufacturing for its client partners, and Vasgene Therapeutics (Los Angeles, California), a clinical-stage company dedicated to the development and commercialization of innovative therapeutics based on the understanding of vascular biology, today announced the successful completion of large scale cGMP manufacture of Vasgene’s recombinant fusion protein for use in its Phase I clinical trial.
“We have enjoyed an excellent working relationship with Vasgene,” said Leigh N. Pierce, President and Chief Scientific Officer of PacificGMP. “Vasgene’s novel technology shows tremendous promise for a vital area of therapeutic need, and we at PacificGMP are honored to have supported their effort by optimizing, scaling and manufacturing their human clinical trial material.”
“Using our 500 liter capacity Wave bioreactor platform, we produced and subsequently purified enough of Vasgene’s recombinant fusion protein to aseptically fill over 2500 vials,” Kristin DeFife, Vice President of Operations at PacificGMP said. “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 Contract Manufacturing Organization 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., Co-founder and Director.
PacificGMP is a contract manufacturer and industry leader in single-use technology for development and manufacturing of biologics. Single-use technology eliminates the risk of cross-contamination, has fewer system requirements and significantly reduces the time required to initiate production. Benefits to clients include rapid project turnaround and the most cost effective solution in the industry. PacificGMP partners with drug developers by providing a range of cGMP and non-GMP services from cell line optimization, early process design, development and scale-up, to preclinical and clinical manufacturing, purification, aseptic filling, analytical services and regulatory support. More information can be found by visiting the company’s website at www.PacificGMP.com.
About Vasgene Therapeutics
Vasgene is a clinical-stage company dedicated to the development and commercialization of innovative therapeutics based on the understanding of vascular biology. Breakthroughs in the basic understanding of the vascular networks combined with powerful new biotechnological tools, have provided the foundation for new, rational, and technologically sophisticated approaches to cancer therapeutics. Vasgene’s aim is to develop therapeutics against novel targets common to cancer cells and endothelial cells, resulting in powerful anti-cancer agents with multiple modes of action: inhibition of tumor cell growth, anti-angiogenesis, and prevention of tumor cell metastasis. For more information on Vasgene Therapeutics, visit the company’s website at www.vasgene.com.