Inactive

This is a Notice of Intent, not a request for proposal. The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) intends to negotiate on an other th... This is a Notice of Intent, not a request for proposal. The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) intends to negotiate on an other than full and open competition basis with Eppendorf North America, 102 Motor Pkwy Hauppauge, NY for cGMP facility inspection and documentation. Laboratory of Malaria Immunology and Vaccinology (LMIV), NIH, NIAID, conducts basic research in malaria immunology and pathogenesis, develops and produces prototype malaria vaccines, and conducts early-phase clinical trials of promising vaccine candidates. The lab's goal is to develop malaria vaccines that will reduce severe disease and death among African children and pregnant women and to eliminate malaria from low-transmission areas of the world. The LMIV Vaccine Development Unit develops and performs clinical evaluation of prototype malaria vaccines. Each candidate vaccine has to undergo a rigorous development process that requires the input of many highly skilled scientists with specific areas of expertise. These include creation of expression systems, fermentation optimization, scale-up of purification technology, clinical good manufacturing practices (cGMP) production, formulation, quality control, preclinical testing, and clinical trials. The LMIV currently owns one BioFlo Pro 75 fermentation skid that is housed in the Pilot Plant in Building 29B in Bethesda MD. LMIV has conducted several meetings in an effort to request that this space be approved for conversion into a cGMP manufacturing suite for the generation of malaria vaccine candidates for use in human clinical trials. This service will fulfill that requirement. Place of performance is Bethesda, MD. The statutory authority for this sole source requirement is 41 U.S.C. 253 (c) (1) as implemented by FAR 6.302-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL. All responsible sources that could provide comparable services may submit a capability statement that will be considered by email (subject line to reference NOI-NIAID-2015445) to Jennifer Walker at jewalker@niaid.nih.gov by 10:00am eastern standard time, July 31, 2020. All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.