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The new facility, located in Ness Ziona, Israel, will support clinical phage manufacturing and can be expanded in the future to support commercial-scale manufacturing.
BiomX, an Israel-based microbiome company developing both natural and engineered phage therapies, announced on Aug. 27, 2019 that it has completed the construction of a new state-of-the-art phage manufacturing facility at its headquarters in Ness Ziona, Israel. The new facility will support clinical manufacturing of the company’s phage products and has the capability to be expanded in the future to support commercial manufacturing needs.
Phage are viruses that specifically infect bacteria. BiomX develops a specific composition (or cocktail) of phage that target each of its bacterial targets. Phage manufacturing requires the manufacturing of a specific bacterial strain first. That strain is used in the second stage of phage manufacturing where it is used to host the growth of the phage.
The new facility has been designed to support the necessary manufacturing requirements for BiomX’s future clinical development, including the manufacturing of BX002, a drug candidate phage cocktail designed to target bacterial strains that potentially have a role in the onset and aggravation of inflammatory bowel disease (IBD). Clinical trials for this drug candidate are expected to start in 2020. In its current configuration, the facility can support clinical manufacturing for the company’s future Phase I and Phase II trials in both IBD and primary sclerosing cholangitis (PSC). It can also be expanded for Phase II and commercial-stage manufacturing.
“In this new age of live biotherapeutics, which include phage as well as human-derived cells and bacteria, manufacturing has become a major step on the path to clinical development,” said Jonathan Solomon, BiomX’s CEO, in a company press release. “Owning and operating our own manufacturing facility provides us with a competitive advantage by allowing close oversight and control, thus enhancing our ability to meet our manufacturing needs in a timely manner. Moreover, the ability to quickly and flexibly respond to new pre-clinical and clinical data allows us to modify our phage cocktails accordingly.”