Date: 2015-06-03
Type of information: Validation of a production plant
Compound:
Company: AmpliPhi BioSciences (USA - VA)
Therapeutic area: Infectious diseases
Type agreement: validation of a production plant
Action mechanism:
Disease:
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Financial terms:
Latest news: * On June 3, 2015, AmpliPhi BioSciences, a global leader in developing bacteriophage-based antibacterial therapies to treat drug resistant infections, announced that its production facility in Ljubljana, Slovenia, was cleared by JAZMP, the Agency of the Republic of Slovenia for Medicinal Products and Medical Devices, to manufacture bacteriophages under current Good Manufacturing Practices (cGMP) standards. 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 a comprehensive evaluation of global manufacturing options. The Company ultimately realized the benefits of having its own dedicated facility, enabling more stringent control over its manufacturing operations and eliminating the need for relying on contract manufacturing. 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 (MCBs), Working Cell Banks (WCBs), Master Viral Seeds (MVSs) and drug substance (DS) from S. aureus bacteria and phages, which were selected from extensive in-house libraries on the basis of strict criteria, resulting in pure, reproducible, high quality and cost-effective therapeutic preparations
