Redacted_J_and_A_1977154.docx

Justification for Other than Full and Open Competition:

Brand-Name at or Below the Simplified Acquisition Threshold Project Title: Advanced Biosystems OsmoTech Osmometer

I. Identification of the agency and contracting activity

DHHS, NIH, NIAID, Vaccine Research Center (VRC), Vaccine Production Program (VPP)

II. Description of the project, and supplies or services required to meet the agency’s needs

A. Project Background:

The Vaccine Production Program (VPP) is the development arm of the Vaccine Research Center. The mission of the VRC is to create and develop potentially lifesaving vaccines for HIV, Ebola, Zika, and other known pathogens and get these potentially lifesaving products into the clinic. To manufacture and release these products for clinical use, analytical assays are developed at the VPP and transferred to the VCMP (Vaccine Clinical Materials Program), the cGMP manufacturing arm of the VRC located in Frederick Maryland. To ensure that the assay results generated at the VPP during product development align with those generated at the VCMP (agreement between values is CRITICAL to release of vaccine for use in lifesaving clinical trials), the same methodologies and equipment manufacturers must be employed at both sites. Currently the VCMP uses a method for measurement of osmolality of drug product based on Vapor Dew Point. This method has known reproducibility issues and the variability is inconsistent between clinical products. The VPP uses the freezing point depression method, which possesses increases reproducibility, reliability, and ease of use. The instrumentation being requested is a Freezing point depression Osmometer compatable with GMP use that is manufactured by the same company (Advanced Instruments) as those in use in multiple groups within the VPP. This offers the least risk of discrepancy between osmolarilty values generated at the two sites, and therefore maximizes the success of clinical manufacture at the VCMP.

B. Description of the supplies to be purchased.

Description of the supplies/services to be purchased include:

III. Identification of the statutory authority permitting other than full and open competition (SELECT ONE)

☒ 41 USC 3304(a)(1) and FAR Part 6.302-1: Only one responsible source / Brand Name

IV. Demonstration that the proposed brand name product’s salient characteristics (specific features, qualities and/or the nature of the acquisition) requires use of the authority cited.

The instrumentation being requested is a Freezing point depression Osmometer manufactured by the same company (Advanced Instruments) as those in use in multiple groups within the VPP. This offers the least risk of discrepancy between osmolarilty values generated at the two sites, and therefore maximizes the success of clinical manufacture at the GMP manufacturing facility/Vaccine Clinical Materials Program (VCMP). In order to be used for GMP manufacturing and testing, the software for the instrument must comply Federal regulation CFR Part 11. Use of an alternate product will increase the risk of delay in release of clinical drug product, or even rejection of drug product lots (approximate loss of $1-2 million per manufactured lot), and will manifest delays within the clinical trials group of the VRC and delay testing of potentially lifesaving vaccines.