San Diego, California – Phage Pharmaceuticals, Inc., a manufacturer of therapeutic proteins, has received a drug manufacturing license from the California Department of Public Health, Food and Drug Branch (CA FDB). Prior to issuing the license the FDB inspected the manufacturing facility and Phage has demonstrated compliance with all applicable state laws including the federal current Good Manufacturing Practices (cGMP).
Jamie Oliver, CEO of Phage Pharmaceuticals, said: “Acquiring this license is another milestone for Phage’s quality program and for our goal of commercializing our products. This demonstrated our continued commitment and compliance to the FDA quality system regulations.” Oliver went on to say, “Phage’s current strategy will utilize the facility to manufacture their clinical development compounds as well as provide GMP material for our partners.”
Phage has a proprietary E. coli bacterial expression system for non-glycosylated proteins which results in the production of properly folded therapeutic proteins, and has the capacity to produce biosimilar and novel proteins for R&D and clinical-scale lots. The Company’s proprietary manufacturing process results in lower production costs and is associated with fewer waste by-products and impurities compared with conventional methods used in the manufacture of similar therapeutics. The Company maintains open INDs with the U.S. FDA for clinical development of FGF-1 and human growth hormone (“hGH”), both of which have shown proof of clinical safety and demonstrated efficacy in humans.
For more information on Phage Pharmaceuticals call 1-858-427-9100 or visit www.phagepharma.com.