First cGMP-certified manufacturing facility commissioned to manufacture bacteriophage products for human use
AmpliPhi BioSciences, a global leader in developing bacteriophage-based antibacterial therapies to treat drug resistant infections, has 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 practice (cGMP) standards.
AmpliPhi will produce Staphylococcus aureus and Pseudomonas aeruginosa bacteriophages to be used in planned human clinical trials. ‘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,’ said M. Scott Salka, CEO of AmpliPhi.
‘In addition, this clearance allows us to advance our proprietary clinical programme and validates our technology platform for a broad range of bacteriophage therapeutic applications and collaborations,’ he added.
AmpliPhi commissioned its production facility in early 2014 after conducting a comprehensive evaluation of global manufacturing options. The company ultimately realised the benefits of having its own dedicated facility, enabling more stringent control over its manufacturing operations and eliminating the need to rely on contract manufacturing.
‘The certification of our manufacturing facility is an important corporate accomplishment, allowing the company to supply drug candidates for our upcoming clinical trials,’ said Salka.