First cGMP facility commissioned to manufacture bacteriophage products for human use
AmpliPhi BioSciences, a US developer of bacteriophage-based antibacterial therapies to treat drug resistant infections, has been approved to manufacture bacteriophages under current cGMP standards at its production facility in Ljubljana, Slovenia.
The facility was cleared by JAZMP, the Agency of the Republic of Slovenia for Medicinal Products and Medical Devices and will produce Staphylococcus aureus and Pseudomonas aeruginosa bacteriophages to be used in planned human clinical trials.
Scott Salka, CEO of Richmond, Virginia-based AmpliPhi, said: '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.'
He added that the approval also allows the company to advance its clinical programme and validates its technology platform for a range of bacteriophage therapeutic applications and collaborations.
AmpliPhi commissioned its production facility in early 2014. The 600m3 plant includes clean areas of various grades (A–D), which meet the particular needs of each step in the manufacturing process and 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 in-house libraries and resulted in pure, reproducible, high-quality and cost-effective therapeutic preparations.
'The certification of our manufacturing facility is an important corporate accomplishment allowing the company to supply drug candidates for our upcoming clinical trials,' added Salka.