PacificGMP Signs Agreement With USC

PacificGMP and the University of Southern California (USC) have signed an agreement whereby PacificGMP will provide development and manufacturing services for USC.

Under the terms of the agreement, PacificGMP will provide process scale up development, cGMP manufacturing and aseptic fill and finish of purified human recombinant type VII collagen.

Reportedly, the recombinant protein will be tested in a phase 1 clinical trial for treatment of dystrophic epidermal bullosa (DEB).

David Woodley, founding chair of the Department of Dermatology at the Keck School of Medicine and Director of the Residency Training Program in Dermatology, said: 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.

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, he added.