AmpliPhi Biosciences Gets First cGMP Certification for Bacteriophage Facility

Regulatory News

AmpliPhi Biosciences announced Wednesday it has received the first ever good manufacturing practices certification for its bacteriophage facility in Slovenia.

Background

Bacteriophages are naturally occurring viruses that are capable of fighting bacteria. Phage therapy has been around for nearly a century, following the co-discovery of bacteriophages by Frederick Twort and Felix d'Hérelle in 1915 and 1917, respectively.

Shortly thereafter, scientists began developing phage therapies to treat different infections, such as dysentery and cholera. However, after the discovery of penicillin, the use of antibiotics eclipsed phage therapy in most of the world except the Soviet Union, where antibiotics were difficult to obtain.

Now, interest in phage therapy, which uses viruses to treat bacterial infections, is on the rise as scientists and health authorities have sounded the alarm on drug-resistant disease. While there are many potential issues with phage therapy, some scientists think it has the potential to provide more targeted treatment versus broad-spectrum antibiotics.

Along with the increase in interest, researchers have called for a greater focus on well-regulated clinical trials and dedicated legal frameworks for phage therapy.

GMP Certification

In a press release Wednesday, AmpliPhi said its facility in Ljubljana, Slovenia has become the first manufacturing site to receive GMP certification to manufacture bacteriophages for human use.

The company said it plans to move forward with a clinical program to investigate the use of bacteriophages to fight staphylococcus aureus and pseudomonas aeruginosa, and said receiving GMP certification clears the way to try other applications in the future.

AmpliPhi said it carefully considered GMP when commissioning the facility and found it would have more precise control than if it relied on contract manufacturing.