In 2003, as multi-drug resistant (MDR) bacteria was starting to pose a serious international health risk, National Institutes of Health (NIH) scientist Carl R. Merril, MD, published a pivotal article that outlined prior limitations of phage therapy and suggested concepts that have emerged as the modern approach. In 2010, the Biological Defense Research Directorate (BDRD) of the US Navy began an initiative to explore Dr. Merril’s concepts as a potential way to deal with biodefense threats associated with MDR superbugs. In 2016 this approach achieved a significant milestone with the successful rescue of Tom Patterson, a critically ill A. baumannii infected patient. Tom Patterson’s case was immediately followed by numerous additional patient cases. In response for the need to translate the Navy’s phage research into a commercially available therapy, Adaptive Phage Therapeutics (APT) was founded by Dr. Merril and his son Greg Merril. The company acquired world-wide exclusive rights to BDRD’s phage technology and began efforts to optimize precision phage therapy for rapid, cost effective, clinical adoption.
In September 2017, APT opened state-of-the-art BSL2 labs and phage manufacturing facilities designed to FDA GMP ICH Q7A and ISO Class 8 standards. This is the only facility of its kind specifically focused on rapid and precise delivery of phage therapy. APT’s facility is strategically located in Gaithersburg, Maryland – within 50 miles of FDA, BDRD, NMRC, Walter Reed Military Hospital, Johns Hopkins, and NIH. APT’s facilities are unique as they were designed from the ground up specifically for manufacturing patient specific therapeutic phage products. The facility includes a dedicated clean room and separate phage amplification and purification lab that is built to GMP and GLP guidelines. There is an extensive set of standard operating procedures: for the use, cleaning, and validation of equipment; the purchase, tracking, and storage of supplies; and for training personnel.
APT’s aseptic fill/finish facilities have been designed to overcome the biggest challenges related to our phage therapy approach. A typical drug compound (a small molecule or a biologic) with standard production techniques will take multiple days to set up and complete a fill process. APT’s PhageBank™ includes hundreds of different phage so traditional manufacturing would require years to complete inventory to support the clinical trials and longer to complete inventory for commercialization. That is unacceptable, so APT has made a significant investment in a state-of-the-art, first of its kind, automated aseptic fill system that automates 6-log decontamination between batches. This innovative system allows APT to fill up to three different batches per day per fill room and can be further scaled up as required.