For Immediate Release
PacificGMP and USC to Collaborate on Recombinant Protein Development and Manufacturing for Phase 1 Clinical Trial
SAN DIEGO and LOS ANGELES, July 27, 2009 - PacificGMP, the leader in single-use bioprocessing for development and manufacturing for its client partners, and the University of Southern California (USC) announced today that they have signed an agreement whereby PacificGMP will provide development and manufacturing services for USC. Under terms of the agreement, PacificGMP will provide process scale up development, cGMP (current good manufacturing practices) manufacturing and aseptic fill and finish of purified human recombinant type VII collagen. The recombinant protein will be tested in a Phase 1 clinical trial for treatment of dystrophic epidermal bullosa (DEB), a rare disease in children born with defects in the gene that encodes type VII collagen. DEB is characterized by extremely fragile skin, recurrent blister formation, scarring and aggressive squamous cell carcinomas. Keck School of Medicine of the University of Southern California researchers David T. Woodley, M.D. and Mei Chen, Ph.D. have studied various therapeutic strategies for DEB and are the principal investigators for the study.
Clinical manufacturing of type VII collagen and related research and development work by Drs. Woodley and Chen is partly funded by a grant from the Epidermolysis Bullosa Medical Research Foundation (EBMRF). More information about the grant and EBMRF can be found by visiting the organization’s Web site at www.ebkids.org.
“PacificGMP is committed to working with Drs. Woodley and Chen and with institutions like USC to assist in the development of treatments for devastating diseases such as DEB,” said Leigh N. Pierce, President of PacificGMP. “It gives us great pride to work with a team so determined to develop treatments for this rare but debilitating disease.”
“We appreciate the PacificGMP team’s understanding of the great medical need for treatments for DEB and, since the work is primarily funded by non-profit sources, their willingness to perform the clinical manufacturing in a significantly cost-effective manner,” said David Woodley, M.D., founding chair of the Department of Dermatology at the Keck School of Medicine and Director of the Residency Training Program in Dermatology. “Skin in children with DEB lacks anchoring fibrils that normally connect the epidermal layer of the skin to the dermis causing the skin’s layers to separate, blister and slough off at the slightest insult or injury. There are currently only palliative treatments for DEB, so it is exciting to establish this partnership with a CMO that is able to quickly initiate drug manufacturing for the clinical trial.”
About PacificGMP, Inc.
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, cell banking, early process design, development, purification and scale-up, to preclinical and clinical manufacturing, aseptic filling, testing, analytical services and regulatory support. More information can be found by visiting the Company’s Web site at www.pacificgmp.com.
About Keck School of Medicine of USC
The Keck School of Medicine of University of Southern California is among the nation's leaders for innovative clinical care, research and education of future physicians. Located on the university's 30.8-acre Health Sciences Campus three miles northeast of downtown Los Angeles, the school's physicians staff neighboring USC University Hospital, USC Norris Comprehensive Cancer Center and Hospital, and the Los Angeles County+USC Medical Center, one of the largest teaching hospitals in the United States. The Mission of the Keck School of Medicine of USC is to improve the quality of life for individuals and society by promoting health, preventing and curing disease, advancing biomedical research and educating tomorrow's physicians and scientists. For more information on Keck School of Medicine of USC visit http://www.usc.edu/schools/medicine/index.html.
Gary L. Pierce, General Counsel and Chief Business Officer of PacificGMP LLC, phone: 1-858-550-4094, firstname.lastname@example.org