About Adaptive Phage Therapeutics

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.