2_BRANDNAME JUSTIFICATION.pdf

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

Project Title: Antibody discovery and vaccine evaluation

I . Identification of the agency and contracting activity

DHHS, NIH, NIAID, VRC, BRS

Address of the requesting lab/office: 40 Convent Drive, Room 2609B, Bethesda, MD 20892

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

A. Project Background In order to study immune responses of experimental samples, it is sometimes necessary to test crude, unpurified samples. This allows researchers to study molecular interactions and binding kinetics in samples that just can not be run on other similar platforms. The Octet system that is currently in place in the lab enables direct determination of active protein concentrations with tight CVs and a broad dynamic range, without the need for detection reagents. With this technolog, researchers can perform comprehensive structure/function studies with large panels of structural variants.

B. Project Description The Vaccine Research Center (VRC) is developing vaccines against HIV and other pathogens. In order to achieve the goals of the VRC, the BRS needs to purchase biosensors for the Octer instrument. These biosensors support the Octet system in place in the lab. With this technology, researchers are able to study: antibody and antibody fragment characterization, protein-protein and protein-peptide interactions, Protein DNA/RNA interactions, protein-lipid interactions, virus and vaccine research, and protein-small molecule interactions. These biosensors are designed to immobilize proteins for binding and kinetic characterization of biomolecular interactions. The proprietary sensors provide the same precise and reliable binding and kinetic values. This project measures antigen, peptide and antibody interactions. Sensors are ordered to match the specific characteristic of the antibodies and epitopes being evaluated in a given experiment.

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

☒ 41 USC 253(c)(1) a n d F A R P a r t 6 . 3 0 2 - 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)

SARTORIUS CORPORATION

565 JOHNSON AVE

BOHEMIA, NY 11716

Tel: 1800635-2906

LPS.OPM.NA@SARTORIUS.COM

B. Describe why only the requested supply/service will meet the government’s needs Other methods, like AR technology, reduce the sensitivity of the assay. It is vital that the lab makes use of the most sensitive assays possible to ensure the generation of reliable data. The requested biosensor technology has been shown to produce the most reliable and precise data, which will be used for publication. The desired technology should allow the researcher to perform rapid immobolzation of proteins and peptides, kinetic analysis of ligand-analyte pairs, and rapid assay development, while producing low CVs and response rates required for determining the binding and kinetics. In this request, we are requesting SAX biosensors, which have a high sensitivity and have undergone additional quality controls to ensure that there is minimal variation between sensors within each lot.

This is vital to our experiments, which utilize many sensors over multiple experimental runs and allows minimal mailto:LPS.OPM.NA@SARTORIUS.COM waste and the ability to more precisely compare results from sensor to sensor and day to day.

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

Sartorious is the only vendor able to provide the dip and read SAX biosensors needed by the lab. They are able to provide a wide variety of different kinds of biosensors, all of which are designed for compatibility with the Octet that is in place in the lab. Use of other products would result in reduced sensitivity and accuracy of the assays.

Because of their status as industry leaders in this type of technology, their technical expertise is unparalleled. They are able to offer scientific advise and troubleshooting for problematic experimental models. This would not be possible if other tyoes of biosensors are ordered because each vendor uses proprietary technology. Use of other supporting products with the Octet would result in the Octet technical people being unable to help with troubleshooting and advice.