Ampliphi Biosciences Corp (OTCMKTS:APHB) a global entity in formulating bacteriophage-reliant antibacterial treatments for drug resistant infections disclosed that its production facility based in Slovenia has been approved by JAZMP. It now has approval for manufacturing of bacteriophages as per cGMP standards. Now, it has permission to manufacture Pseudomonas aeruginosa as well as Staphylococcus aureus to be utilized in scheduled human clinical studies.
The expert view
Scott Salka, the Chief Executive of Ampliphi, stated that the acceptance is a fundamental regulatory achievement that further reinforces company’s leadership in the market of bacteriophage. After the approval, the company becomes the sole firm with cGMP-approved manufacturing facility around the world. It is dedicated to develop bacteriophage products used in human applications. In addition, this approval forms a strong platform for the company to advance with proprietary clinical program. The advanced technology platform can be used for numerous bacteriophage therapeutic applications.
The benefits of self-owned facility
Ampliphi structured its production facility back in 2014 after completing a comprehensive review of overall manufacturing alternatives. It eventually recognized the advantages of having own dedicated facility. The self-owned facility offers complete control over manufacturing tasks and minimizes the reliance on contract manufacturing. Ampliphi facility spread on 600 sq. meter area covers clean spaces of several grades developed to fulfill the specific needs at different levels of the manufacturing process.
The past record
Ampliphi Biosciences Corp (OTCMKTS:APHB) has already formulated Master Cell Banks, Master Viral Seeds, Working Cell Banks, and drug material from S. aureus ‘bacteria’ and ‘phages’. The mentioned drug substances were taken from in-house libraries after they have passed stringent criteria. The aim was to obtain high quality, affordable, reproducible and pure therapeutic preparations. Salka further said that the cGMP validation for production facility based in Slovenia is a significant corporate win enabling the company to deliver drug candidates for listed clinical trials.