U.S. company gets cGMP certification for Slovenia plant to produce bacteriophages

A Richmond, VA-based company that is developing virus-based treatments to fight antibiotic-resistant bacterial infections has gotten its plant in Slovenia certified by authorities there. With that, AmpliPhi Biosciences claims it has the only cGMP-certified manufacturing facility in the world dedicated to producing bacteriophage for human use.

A spokesman for the company said AmpliPhi made a "multi-million Euro investment in the cGMP facility," which it commissioned last year. It selected Slovenia due to the country's established manufacturing infrastructure and "unique access to a skilled workforce." Phage therapy, in which highly selective viruses target bacteria, dropped from use in the U.S. in the 1920s and 1930s after the advent of the much easier-to-produce antibiotics. It, however, continued to be used for years in the former Soviet Republic and is used still in parts of Central and Eastern Europe.

About 15 people will work at the 600-square-meter facility in Ljubljana to manufacture drug substance for the company's upcoming clinical trials on a number of infections, including methicillin-resistant Staphylococcus aureus infections. AmpliPhi has already produced master cell banks, working cell banks, master viral seeds and drug substance from S. aureus bacteria and phages.

The company said having its own manufacturing facility gave it needed control over the process and eliminated the need for contract manufacturing. AmpliPhi, which is working on projects with the U.S. Army and others, said it expects to eventually seek FDA approval for its therapies but for now, the certification from the Agency of the Republic of Slovenia for Medicinal Products and Medical Devices is all that is needed to produce product for trials.

"The certification of our manufacturing facility is an important corporate accomplishment allowing the company to supply drug candidates for our upcoming clinical trials," CEO M. Scott Salka said in a statement.

With the emergence in recent years of antibiotic-resistant "superbugs," there has been a big push in the U.S. to develop new therapies to treat the infections they cause. The White House last year issued a multifaceted plan that is supporting the development of new treatments, mostly new antibiotics, while moving to reduce the general use of antibiotics in food animals, which is thought to be a factor in antibiotic resistance.

One of the front-runners in development of new antibiotics has been Cubist, which in December, Merck ($MRK) agreed to buy for $9.5 billion. The Lexington, MA-based Cubist has a portfolio of marketed meds--including its top performer Cubicin and newly approved Sivextro--and a pipeline of other treatments aimed at drug-resistant infections.

- here's the release

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