Justification_for_Other_than_full_and_open_competition.pdf

Justification for Other than Full and Open Competition at or Below the Simplified Acquisition Threshold

Project Title: Plasmid synthesis

I . Identification of the agency and contracting activity

II. Description of the project, and supplies or services required to meet the agency’s needs (including the estimated value)

The Vaccine Research Center at the National Institutes of Health will conduct research that facilitates the development of effective vaccines. Towards this end, our 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 candiates, monoclonal antibodies and proteins used in assays to evaluate the qualitity of the vaccinations and antibodies being evaluated.

A. Project Description

The Biodefense Research Section of the Vaccine Research Center at the National Institutes of Health develops vaccines and monoclonal antibody therapies for the treatment of biodefense related pathogens such as Ebola virus, Sudan virus, Bundibugyo virus, Marburg virus and Lassa Fever virus. These efforts requires the synthesis and purification of DNA plasmid reagents and for the development and testing of thereapeutic antibody and vaccine candidates. The services that are being purchased will provide these materials.

III. Identification of the statutory authority permitting other than full and open competition (SELECT ONE) ☒ 41 USC 1901(e)(2) a n d F A R 1 3 . 1 0 6 - 1 : Only one responsible source

IV. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

A. Name and address of the proposed contractor(s)

GenScript USA Inc.

860 Centennial Ave.

Piscataway, NJ 08854, USA Tel:732-885-9188 Fax:732-210-0262 Molly.Jia@genscript.com

B. Describe why only the requested supply/service will meet the government’s needs

The requested services for synthesis of DNA coupled with protein production/purification. The vendor has previously synthesized DNA sequenceces for VRC and supplied these in plasmid custumized VRC DNA vectors. The sequence verify and deliver the final DNA after additional quality controls to VRC. The service being provides custom DNA synthesis and vector purification.

C. Describe why only the proposed contractor is capable of providing the requested supply/service

The VRC and BRS has been using Genscript for DNA synthesis, plasmid production and protein purification for years, and has been incorporated Into the Federal Drug Administration’s (FDA) approved protocol for clinical trial. In particular, the protein production, purification and quality control services being requested are highly customized to our particular needs and based on our extensive past experience, Genscript has proven capable of meeting the demands of these protocols and providing the expected high-quality product that our experiments demand. Changing vendors would lead to variations in final product that would lead to the loss of integrity of our data.