Ambient-Stable Biologic Product Formulation

The contract seeks the development of advanced stabilization techniques to enable biologic products to maintain full efficacy when stored at ambient temperatures ranging from 20 to 25 degrees Celsius, with a target shelf life of 2 to 5 years. This effort is focused on overcoming the current reliance on cold-chain logistics by creating formulation solutions that preserve structural integrity, biological activity, and safety of sensitive biologics under real-world storage conditions. The work will involve innovative approaches in excipient design, lyophilization, nano-encapsulation, or other emerging technologies that prevent degradation pathways such as aggregation, deamidation, and oxidation without the need for refrigeration. This subcontract is issued by the Agency for Strategic Preparedness and Response within the Department of Health and Human Services under NAICS code 325412, which covers pharmaceutical and biological product manufacturing. The opportunity was posted on July 28, 2026, with a response deadline of August 28, 2026. Performance is expected to take place in the area associated with ZIP code 77416, though no specific city or state is provided. The contract aims to bolster national preparedness by ensuring reliable access to life-saving biologics during emergencies, in resource-limited settings, or in regions with inconsistent infrastructure, reducing dependency on temperature-controlled distribution systems.