Variant Genes in Support of COVID-19

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), intends to negotiate on an other than full and open competition basis with GenScript USA Inc., 860 Centennial Ave, Piscataway, New Jersey 08854-3918 to continue with obtaining rapid and reliable synthesis and cloning of selected priority variants of SARS-CoV-2 genes for use in assays to test the neutralization potency of antibody therapeutics candidates, convalescent plasma, ad sera or plasma from vaccine recipients. This shall be performed with the following task: Gene Synthesis qty-150, Mutagenesis qty-150, Express Cloning qty-250, and Plasmid Preparation qty-425. See the attached Statement of Work.

This acquisition will be processed under FAR Part 12 Acquisition for Commercial Items and will be made pursuant to the authority in FAR Part 13.501(a)(1).

Only one award will be made as a result of this solicitation. This will be awarded as a firm-fixed price type of contract.

Delivery to Rockville, Maryland 20852 with a period of performance for one (1) year from date and acceptance of award.

This requirement is needed as a direct result of the COVID-19 pandemic. On March 11, 2020, the World Health Organization declared the COVID-19 outbreak a global pandemic, and on March 13, 2020, the united States issued a Presidential Proclamation declaring the COVID-19 outbreak to be a national emergency. Additionally, all fifty states and the District of Columbia have declared emergencies due to COVID-19. This mission is to respond to the community spread of COVID-19 throughout the United States.

The NIAID urgently requires access to services that provide rapid and reliable synthesis and cloning of selected priority variants of SARS-CoV-2 genes for use in assays to test the neutralization potency of antibody therapeutics candidates, convalescent plasma, and sera plasma from vaccine recipients. GenScript USA has the specific plasmid needed for pseudovirus generation that is not widely available, which is pivotal for consistency with 200+ other constructs already ordered, and has been used by the laboratory for previous assays, which is required for the reagents to be assay-ready. GenScript USA has demonstrated specific experience rapidly synthesizing SARS-CoV-2 spike genes, including multiple complicated mutations and deletions.

Importantly, GenScript USA has already provided an initial set of variant gene plasmids that are being used in assays to test vaccines and therapeutics. Therefore, they have the required plasmid and template Spike gene in-hand and ready for use in preparing new variants as they are requested as well as the ability to rapidly resupply existing variants as needed. Changing to another set of variant genes from another vendor would lead to spending additional funding to start the experimental processes that are in progress all over again. Many of the variants of SARS-CoV-2 evolve from existing dominant versions of the virus, generally with a limited number of amino acid changes. As a result, the existing library of plasmids provides a set of available templates, which can be used to generate new spike variants using mutagenesis. This provided the advantage of cheaper cost and quicker turn-around than if de novo synthesis would be required, in the absence of the existing library of plasmids. If a new vendor is used, we would need to resynthesize from scratch more than 450 genes in order to recreate the library of spike variants that are already in hand at GenScript USA Inc. Using the same vendor set-up time will be avoided. GenScript USA Rush Synthesis designation offers a fast turn-around time for easy shipping and avoid delays, which have recently significantly impacted international or even cross-country shipments.

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 source available, no substitutions possible. THIS IS NOT A SOLICITATION FOR COMPETITIVE QUOTATIONS. All responsible sources that could provide the required variant genes may submit a capability statement that will be considered by email (subject line to reference NIAID-NOI-22-2115314) to Tonia Alexander at talexander@niaid.nih.gov, by 11:00 am eastern daylight time Friday, March 18, 2022. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. Any responses received by NIAID after this date and exact time specified is late and will not be considered.