Ampliphi Biosciences Corp (OTCMKTS:APHB) a global pioneering firm in designing bacteriophage-based antibacterial treatments to cure drug resistant infections reported that its production facility in Slovenia was approved by JAZMP. The approval received is for manufacturing of bacteriophages under cGMP standards. The company will manufacture Pseudomonas aeruginosa and Staphylococcus aureus bacteriophages to be utilized in planned human clinical studies.
The expert comments
Scott Salka, the CEO of Ampliphi, said that the approval is a pivotal regulatory achievement that further strengthens company’s leadership in the industry of bacteriophage. It is the company with only cGMP-approved manufacturing facility across world dedicated to developing bacteriophage products for human applications. Moreover, this approval enables the company to progress with proprietary clinical program and certifies technology platform for a wide range of bacteriophage therapeutic use and collaborations.
The measures
Ampliphi built its production facility in 2014 after performing a comprehensive assessment of global manufacturing alternatives. It ultimately recognized the advantages of possessing own dedicated facility. It offers extended control over its manufacturing tasks and reduces the dependence on contract manufacturing. The facility spread on 600-square-meter area includes clean spaces of various grades optimized to fulfill the specific needs in the manufacturing process. It is well designed to meet cGMP standards.
The achievements
Ampliphi has already developed Master Cell Banks, Working Cell Banks, Master Viral Seeds and drug substance from S. aureus bacteria and phages. They were taken from extensive in-house libraries and selected on the basis of stringent criteria, resulting in high quality, cost effective, pure and reproducible therapeutic preparations. The CEO further added that the cGMP validation of manufacturing facility is a significant corporate achievement enabling the company to supply drug candidates for scheduled clinical trials.
In last trading session, the stock price of Ampliphi Biosciences Corp (OTCMKTS:APHB) surged more than 24%to close the trading session at $0.199 on share volume of 2.56 million.
