CGMP ALFQ Manufacturing

THIS IS A NOTICE OF INTENT TO AWARD A SOLE-SOURCE CONTRACT AND IS NOT A REQUEST FOR COMPETITIVE PROPOSALS.The U.S. Army Medical Research Acquisition Activity (USAMRAA) intends to award a sole source basis in accordance FAR 6.302-1 with Evonick Corporation, 299 Jefferson Road, Parsippany, NJ 07054-2827 as the only responsible source that can manufacture Army Liposome Formulation with QS21 (AFLQ) under cGMP conditions.BackgroundWalter Reed Army Institute of Research (WRAIR) a subordinate laboratory of the U.S. Army Medical Research and Development Command conducts biomedical and behavioral health research that is responsive to Department of Defense and US Army requirements and delivers life-saving products including knowledge, technology and medical material that sustain the combat effectiveness of the Warfighter. This effort is in support Phase 1 /2 Clinical Trials on behalf of the HIV and emerging infectious diseases vaccine development programs. WRAIR has a requirement to manufacture

100,000 doses (minimum of 20,000 doses/lot) of ALFQ under cGMP conditions in accordance with the Department of Defense (DOD) Acquisition System, FDA, MHRA and EMA regulations and guidelines, and industry best practices.The ability to produce ALF55 is a key component of this requirement. Due to the specialty skills and equipment required to make ALF55, there is only one vendor that has the capability to manufacture ALF55. Evonik Corporation is the only vendor with the specialized personnel, processes, procedures, and equipment needed to produce ALF55 which is required to produce ALFQ.The intended acquisition will be classified under North American Industry Classification System (NAICS) 541714 Research and Technology in Biotechnology (except Nanobiotechnology), with a size code of 1,000 employees.This announcement fulfills the synopsis requirements under FAR 5.102(a)(3) and 5.203(a)(1). USAMRAA intends to release a solicitation no sooner than forty-five (45) days after publishing this synopsis. This Special Notice of Intent (NOI) is not a request for competitive quotes. Meaningful submissions received in response to this notice will be considered solely for the purpose of determining whether a competitive procurement is in the best interest of the Government. If no meaningful, written submissions are received by the date listed below, which reflects at least forty-five (45) days after the publication of this notice, the solicitation will be issued as a sole source requirement to the Evonik Corporation.All responses concerning this notice shall be emailed to Rebecca Wisner at rebecca.c.wisner.civ@health.mil.Interested concerns must identify their capability in writing to the above e-mail address no later than 10:00 AM Eastern Daylight Time (EDT), 08 May 2023. No phone calls accepted.