AmpliPhi BioSciences Gains OK for GMP Bacteriophage Mfg Facility
AmpliPhi BioSciences Corporation, a company developing bacteriophage-based antibacterial therapies to treat drug-resistant infections, has received approval from JAZMP (the Agency of the Republic of Slovenia for Medicinal Products and Medical Devices) to manufacture bacteriophages under current good manufacturing (cGMP) practices at its production facility in Ljubljana, Slovenia. AmpliPhi will produce Staphylococcus aureus and Pseudomonas aeruginosa bacteriophages to be used in planned human clinical trials.
AmpliPhi commissioned its production facility in early 2014 after conducting an evaluation of global manufacturing options. The 600-square-meter facility includes clean areas of various grades (A-D), optimized to meet the particular needs of each step in the manufacturing process and designed to comply with cGMP standards. The company has already produced master cell banks working cell banks, master viral seeds, and drug substance from S. aureus bacteria and phages, which were selected from in-house libraries.
AmpliPhi BioSciences is headquartered in Richmond, Virginia and research facilities in Richmond and Brookvale, Australia. The company was founded in 1989 as a wholly owned subsidiary of Immunex Corporation and began operations as an independent company in 1992 as Targeted Genetics Corporation. In 2011, it acquired Biocontrol, an antimicrobial biotechnology company based in the United Kingdom, with the goal of developing phage-therapy programs using funding from the sale of its legacy gene therapy assets. In 2011, the company changed its name to AmpliPhi Biosciences Corporation. It 2013, it acquired Special Phage Holdings Pty Ltd, a company based in Australia, which specialized in addressing antibiotic resistance through the development of a series of bacteriophage-based treatments.
Source: AmpliPhi BioSciences