H_Redacted J&A.docx

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

I. Identification of the agency and contracting activity

DHHS, NIH, NIAID

II. Description of the project, and supplies or services required to meet the agency’s needs (including the estimated value) A. Type of action. Check the appropriate box:

New requirement: 2000122 ☒ Follow-on B. Project Background:

The Laboratory of Malaria Immunology and Vaccinology conducts basic research on malaria pathogenesis and immunology, with an emphasis on studies in humans who are naturally or experimentally infected with malaria parasites. In parallel, the Vaccine Development Unit—which was launched in 2001 as the Malaria Vaccine Development Unit and then became the Malaria Vaccine Development Branch before taking its current shape—operates more like a small biotech firm than a typical research laboratory. Specialists in each step of the development process, from antigen selection to clinical trials, contribute their expertise as the candidate moves along the development pathway. This allows multiple vaccine candidates to move from concept to clinical trials efficiently and rapidly. Together, the discovery sections and Production Unit form a research and testing enterprise that can rapidly translate ideas into proof of concept trials and then capture basic information about human immunity and responses to infection during human clinical trials.

The aim of the current study is to generate several custom designed genes for the Tolia lab. These gene products will help the staff in the Tolia lab to understand if their expressed and purified product is the same as the designed product. These will be used as a laboratory reagent for testing purification products. Each quote contains several genes to be cloned, shipping costs and handling costs. All requested custom designed genes are required laboratory reagents by the Tolia lab to support Dr. Tolia’s work toward the discovery of a new malaria vaccine for testing in human clinical trials.

III. Justification for Other than Full and Open Competition

a. ☒ 41 USC 1901(e)(2) and FAR Part 13.106-1: Sole Source This request is a sole source because GenScript, because codon optimization is critical to successfully expression of malaria Plasmodium falciparium (Pf) proteins in a recombinant expression system. Different companies use different algorithms for codon optimization and different methods of generating synthetic genes which may generate different results. GenScript’s optimization service has been used in LMIV’s research for many years. Their gene synthesis projects and their codon optimization algorithm work exceptionally well for expression of Pf proteins in mammalian systems. Using a different vendors codon optimization algorithm will not yield the same results for Pf proteins and would cause a significant loss of time and money for LMIV.