The certification that phage therapies made at the site are produced in compliance with current good manufacturing practices (cGMP) allows AmpliPhi to move forward with its clinical development programme according to CEO, Scott Salka.
“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.”
AmpliPhi’s candidate products are bacterial viruses – bacteriophages – that infect and kill bacteria.
The Ljubljana site produces phage therapies that target Staphylococcus aureus and Pseudomonas aeruginosa, which are being prepared for clinical trials.
The 600sqmeter facility, which was commissioned last year, houses cell banks and storage areas for the viral ‘seeds’ that are used to produce the phage. It also has libraries holding various species of pathogenic bacteria used in product development.
Phage therapy
Phage therapy was used extensively in the Soviet Union as access to antibiotics developed in the West was limited.
While the approach is still used in Russia and other former eastern bloc countries, it has never caught on elsewhere.
Quite why this is is unclear, although researchers like Mzia Kutateladze from the Eliava Institute in Tbilisi, Georgia have suggested that (unfounded) concerns about using viruses to treat disease were a factor.
For others it is because, unlike their Soviet counterparts, Western doctors have always had access to antibiotics.
What impact the antibiotics cliff – a combination of increasing resistance to antibiotics and the falling drug industry interest in developing replacements – will have on interest in phage therapy is unclear.
AmpliPhi told us: "The rise of multi-drug resistant bacteria has led to a renewed interest in exploring bacteriophage-based therapies to treat infection and modern scientists have a deeper understanding of how phage work and are making positive strides to introduce new therapies into mainstream medical use."
What is clear is that the EMA is interested phage therapy.
Later this month the agency will hold a workshop on the therapeutic use of bacteriophages citing the “emergence of bacteria that are resistant to most, if not all, currently available antibiotics” as a driver for the meeting.
Update: After this article was published we were contacted by Cobra Biologics which told us that it has made phage under GMP certification for several years.