PacificGMP and University of Southern California to Collaborate on Recombinant Protein Development and Manufacturing for Phase 1 Clinical Trial
Published: Jul 27, 2009
SAN DIEGO and LOS ANGELES, July 27 /PRNewswire/ -- 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.