Published on October 22, 2009 at 6:40 AM
PacificGMP, the leader in single-use bioprocessing for development and manufacturing for its client partners, announced that ArmaGen Technologies has selected it to produce its proprietary protein for a Phase 1 clinical trial. Under the agreement, PacificGMP will use a perfusion process to produce the antibody fusion protein, AGT-190, under cGMP (current good manufacturing practices) standards. Additionally, PacificGMP will perform cGMP cell bank development, a necessary component of clinical material production.
"We are delighted to have been selected by ArmaGen to produce their human clinical trial material," said Leigh N. Pierce, President and Chief Scientific Officer of PacificGMP. "ArmaGen's technology shows excellent progress in a vital area of therapeutic development. We at PacificGMP are excited to be an important part of ArmaGen's team for this project."
"PacificGMP brings considerable expertise in GMP manufacturing and in perfusion bioprocessing. We are pleased to have PacificGMP manufacture AGT-190 and generate our Master Cell Bank, to support our stroke and Parkinson's disease clinical program," said William M. Pardridge, M.D., Chairman, ArmaGen Technologies, Inc.
Perfusion is a production technology whereby culture media containing the drug product is continually harvested while the bioreactor is replenished with fresh media containing essential nutrients. The result is a dense cell culture able to produce necessary yields using a smaller bioreactor size compared to a traditional batch or fed-batch process. By maintaining smaller cell culture volumes and bioreactor size, perfused method manufacturing provides significant economic and timeline advantages.
SOURCE PacificGMP