2_JA 2100484.docx

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

Project Title: Cell Line Development High-Throughput Plasmid Cloning

I. Identification of the agency and contracting activity

II. Description of the project, and supplies or services required to meet the agency’s needs A. Project Background The Cell Line Development team at the VPP is responsible for cloning genes to express monoclonal antibodies and recombinant proteins into our proprietary expression vector backbone for each project that is initiated towards clinical production. Our current approach to this process is with restriction digest-based cloning, which requires several manual steps and takes approximately 2 weeks to get to the final plasmid. It is also relatively low-throughput since all of the steps are done manually. This limits our capacity to generate plasmids for multiple constructs simultaneously.

B. Project Description We are looking to increase our capacity and speed for plasmid cloning without the need for additional staff. The Codex DNA BioXp 3250 system is an automated custom DNA synthesis platform that can support this need.

III. Identification of the statutory authority permitting other than full and open competition ☒ 41 USC 253(c)(1) and FAR Part 6.302-1: Only one responsible source

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

A. Name and address of the proposed contractor Codex DNA 9535 Waples Street Suite 100 San Diego, CA 92121 B. Describe why only the requested supply/service will meet the government’s needs The BioXp 3250 is an automated personal genomic workstation that builds and clones DNA fragments in a process that is basically hands-free. It enables synthesis of up to 32 DNA fragments or clones per run with a timeline of 3-5 days from ordering of materials to the final product. The custom DNA fragments can also be cloned into an expression vector with high efficiency. Acquisition of this system would allow us to rapidly clone multiple constructs for a given project and reduce overall project timelines without adding additional staff or taking time away from other projects.