Armata Pharmaceuticals, Inc., a clinical-stage biotechnology company focused on the development of high-purity, pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections, announced that its state-of-the-art current Good Manufacturing Practice ("cGMP") manufacturing facility in Los Angeles, California, has been formally commissioned. As part of the commissioning process, the U.S. Food and Drug Administration (the "FDA") has been notified that production has commenced, and full production runs have been completed with no issues or concerns.
"The full commissioning of our state-of-the-art manufacturing facility in Los Angeles represents a key milestone for Armata, ensuring that we are operationally ready to initiate pivotal studies of our phage-based therapeutics," stated Dr. Deborah Birx, Chief Executive Officer of Armata. "Importantly, this facility reflects our commitment to onshore manufacturing, from procurement of active pharmaceutical ingredients through fill and finish activities, to ensure that we can achieve the quality, quantity, and consistency of high-purity phage that our clinical programs require, while aligning with the federal government's efforts to further secure the essential medicine supply chain through domestic manufacturing. With this production facility now online, I believe we have taken another meaningful step forward in our quest to ensure that our phage-based therapeutics are available to treat patients in need in the not-too-distant future and reduce reliance on antibiotics that continues to contribute to the antimicrobial resistance crisis."
The facility, which spans 56,000 square feet, includes 10,000 square feet of cGMP clean rooms, an automated fill and finish suite, quality control laboratories for internal testing and release of clinical trial material, research and development laboratories, and administrative space. The facility allows Armata to manufacture its proprietary high-purity, multi-phage cocktails in support of the Company's future clinical trials, including advancement of AP-SA02 into a potential pivotal Phase 3 trial that Armata plans to initiate in 2026, subject to review and feedback from the FDA, as well as to support future commercial production and potential partnering and contract manufacturing opportunities.