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AmpliPhi announces that its new facility in Slovenia has received cGMP certification to manufacture bacteriophages for clinical trials.
On June 3, 2015, AmpliPhi BioSciences announced that its production facility in Ljubljana, Slovenia was cleared by the Agency of the Republic of Slovenia for Medicinal Products and Medical Devices to manufacture bacteriophages under cGMP standards. The 600-square-meter facility will be used to produce Staphylococcus aureus and Pseudomonas aeruginosa for planned human clinical trials. AmpliPhi focuses on developing bacteriophage-based antibacterial therapies to treat drug resistant infections, according to a press release. Completion of the facility allows AmpliPhi to exhibit control of the manufacturing process for bacteria and phages to be used in clinical trials, rather than to rely on outsourcing.
“This clearance is a pivotal regulatory milestone that further supports AmpliPhi’s leadership in the field of bacteriophage with the only cGMP-certified manufacturing facility in the world dedicated to producing bacteriophage products for human use. In addition, this clearance allows us to advance our proprietary clinical program and validates our technology platform for a broad range of bacteriophage therapeutic applications and collaborations,” said M. Scott Salka, CEO of AmpliPhi, in a press release.