Following the experience with a phage-based medical product licensed in Czechoslovakia 30 years ago, we would like to make phage therapy alive again.

MB Pharma gets into phages

“And when did you guys pop up here?” Laurent Debarbieux asked when we met for the first time in Paris. Well, we popped up five years ago in the Czech Republic, when MB Pharma started to focus on phage activities. A few essential ingredients were put together: a team of people interested and experienced in the field, a brave idea to re-activate an old phage-based product already registered in former Czechoslovakia, and a clear vision: that phages could be a future treatment for bacterial infections.

A phage product in former Czechoslovakia

Did you know that a phage-based medical product was previously licensed in the European Union? Developed in the 80s, licensed in the 90s, called STAFAL, it contained phages of Staphylococcus aureus, and was a product of research and development of scientists and experts in former Czechoslovakia. Although the product’s registration has expired, and the whole process will have to start over, the tradition and experience is here. Moreover, the current generation of physicians and medical experts in this region remembers that phage therapy existed, as they used it widely in common practice.

Czech physicians have memories of phage therapy

“So you will produce STAFAL again?” a physician in a Prague hospital asked, when I discussed with her what we did and why. She knew it very well. “When I worked at the department of burn wounds, we were buying tons of it — it was quick and safe. Pity it is not available anymore,” she added, when I explained the situation to her. The interview gave me two important pieces of information: first, phage therapy is really a matter of perspective. Second, we need to be quick, as the generation of professionals remembering it is getting older, and the memory of phage therapy in this region could go extinct soon.

MB Pharma’s dual goals: build a phage product and help others produce GMP phages

Therefore, the main target of MB Pharma was (and still is) simple: to obtain marketing authorisation for an in-house-produced, phage-based product, and to perform all the necessary preceding steps. First, an R&D laboratory was equipped, and the team was established to work on research and development of phage production and testing. Next, another facility was established, focused on GMP phage manufacturing. In 2016, the manufacturing lab was GMP-certified by the Czech Drug Authority, and bacterial and phage lysates started to be produced and released as Drug Substances and Human Investigational Drug Products.

But the process takes a long time, showing more and more hurdles to be passed. Therefore, at the moment, we have split our activities to two ways. We still maintain our pipeline toward running a clinical trial and obtaining marketing authorisation of a phage-based product. Besides that, we serve as a CMO (contract manufacturing organisation) for those who need phages produced both in GMP and non-GMP modes.

Making phage therapy alive again

This is how we would like to set up collaboration in the phage therapy field. Our mission is to support everyone who would like to work with phages. Do not waste your rare time and resources with routine phage production, when we can do it for you. Instead, you can focus on the key part of your projects, where your expertise lies. Because we all have the same target: let’s make phage therapy alive again.