2_JA 2132726 Octet Buffern and Well-plates.docx

Justification for Other than Full and Open Competition:

Brand Name at or Below the Simplified Acquisition Threshold

Project Title: Sartorius Corporation consumable standing order request

I. Identification of the agency and contracting activity

A. Description of the project, and supplies or services required to meet the agency’s needs Project Background The National Institute of Allergy and Infectious Diseases (NIAID) conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. For more than 50 years, NIAID research has led to new therapies, vaccines, diagnostic tests, and other technologies that have improved the health of millions of people in the United States and around the world.

The Vaccine Research Center (VRC) is an intramural research center within NIAID dedicated to discovery and translational science for infectious disease indications. The VRC has full bench-to-bedside capabilities that enable rapid clinical evaluation of VRC discoveries. The VRC’s Vaccine Production Program Laboratory has process, formulation, and analytical development groups and oversees cGMP manufacturing at the VRC’s pilot plant.

Since the VRC/Vaccine Production Program (VPP) group is responsible for developing a scale able GMP process the items requested need to be standardized with what will be utilized in the VRC’s pilot plant and applicable to a GMP process and analytical standards that are used to characterize and release therapeutic and vaccine candidates to treat diseases including Covid-19 (SARS2-CoV), HIV, Influenza, Malaria, and Ebola. Understanding these attributes are required for moving forward with a candidate to GMP manufacturing and clinical trials. We are requesting these Analtyical Development consumable supplies in support of the VPP’s therapeutic and vaccine candidates using the VPP’s 6 Octet instruments.

B. Description of the supplies/services to be purchased List of Materials:

II. Identification of the statutory authority permitting other than full and open competition

☒ 41 USC 1901(a)(1) and FAR Part 13.106-1(b): Only one responsible source/Brand Name

III. 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)

Sartorius Corporation 565 Johnson Avenue Bohemia, NY 11716

B. Describe why only the requested brand or brand name feature of the supply/service will meet the government’s needs

The Octet system is not compatible with any other buffers or well-plates in the market. They are specific to an instrument that require the specific items to be from this manufactured by the requested manufacturer and and have already proven to be effective with our specific biological candidates, are currently under VPP’s Analytical Development SOPs. Additionally, the instruments for which these supplies are being requested are currently in use at the GMP Pilot plant and are currently validated in their process. Attempts to modify the items the VPP utilizies in the development of the next generation vaccine and or theriapeutics would result in the pilot plant having to re tool and then re validated existing materials at the pilot plant. This would then cause significant (greater than 12 months) delays and loss of vaccine development in the Vaccine Research Center.