Inactive

PRE-SOLICITATION NOTICE **NOTICE OF INTENT NOI-NIAID-23-2180374 NAICS – 541380, Testing Laboratories This is a Notice of Intent, not a request for proposal. The National Institute of Allergy and Infec... PRE-SOLICITATION NOTICE **NOTICE OF INTENT NOI-NIAID-23-2180374 NAICS – 541380, Testing Laboratories 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 GenScript USA Inc to procure the production and purification of Nipah F and G virus glycoproteins for ongoing research activities, with results to be used in the evaluation of new vaccine candidates, monoclonal antibodies and protein assays. The Vaccine Research Center (VRC) at the National Institutes of Health conducts research that facilitates the development of effective vaccines. Towards this end, the goal has been to develop vaccine and passive immunotherapies, such as monoclonal antibodies, that can be used as both preventative treatments and acute therapies. This project enables the production of vaccine candidates, monoclonal antibodies and proteins used in assays to evaluate the quality of the vaccinations and antibodies being evaluated. The ImmunoTechnology Section, part of the Vaccine Research Center, develops vaccines and monoclonal antibody therapies for the treatment of biodefense related pathogens such as Nipah and Hendra viruses. These efforts require highly purified and functional proteins for use as reagents in order to evalute therapeutic antibodies and vaccine candidates. The goal of this project is to produce and purify Nipah F and G virus glycoproteins. Those proteins are essential to continue on-going research activities and perform assays to inform on vaccines immunogenicity and antibodies binding capacities. For that purpose, it is essential that the protein used in any in-vitro assays is pure with no side-products to ensure that the observed effects are not bias. GenScript provides high quality recombinant proteins to support a variety of applications in drug discovery and vaccine research and uses a proprietary transient mammalian expression technology to modify cellular pathways in order to achieve optimal protein yield. They also optimized expression protocol and growth media to maximize the cells longevity, for guaranteed gram-level recombinant protein expression projects. GenScript is using high density transient expression service which can deliver high yield of proteins (100 fold than regular methods) in a shortened turnaround time (less than 10 weeks from sequence to protein production/purification). GenScript has been working closely with the VRC over the past few years to establish VRC-specific, customized modifications to production and purification protocols, as well as quality control assays. This establishment ensures that the proteins and antibodies GenScript provided fully satisfy VRC’s high standards and specific downstream applications prior to approval by the FDA. The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as implemented by FAR 13.106-1 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-23-2180374 to Dana Monroe at dana.monroe@nih.gov, by 5:00 pm eastern standard time Tuesday, June 27, 2023. 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.