SAN DIEGO, Oct. 22 /PRNewswire/ -- 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.
About PacificGMP
PacificGMP is a contract manufacturer and industry leader in applying 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, testing, analytical services and regulatory support. More information can be found by visiting the Company’s Web site at www.PacificGMP.com.
About ArmaGen Technologies
ArmaGen Technologies is a privately-held biotechnology company developing therapeutic products for the central nervous system. ArmaGen re-engineers recombinant proteins to enable transport across the blood-brain barrier (BBB) and penetration into the brain. With ArmaGen’s molecular Trojan horse technology, a new fusion protein is created wherein the protein therapeutic is fused to the Trojan horse, a genetically engineered monoclonal antibody that crosses the BBB via an endogenous peptide transport system. For more information on ArmaGen Technologies, visit the Company’s Web site at www.armagen.com.
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Leigh Pierce
http://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=67271
SOURCE PacificGMP
CONTACT: Andrea Lynn, Marketing Director of PacificGMP, +1-858-550-4094,
ext. 410
Web site: http://www.pacificgmp.com/
http://www.armagen.com/
