REDACTED JOFOC - MSD - MC Signed and AMBIS Number.pdf

Justification for Other than Full and Open Competition:

MesoScale Discovery at or Below the Simplified Acquisition Threshold

Project Title: Quantification of monoclonal antibodies in serum to determine the PK levels/Immunogenicity of vaccines

I . Identification of the agency and contracting activity

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 Follow-on

Name of the previous contractor(s): Meso Scale Discovery Sequence number, if available: ____________________________________ Was the initial and any subsequent awards competed? Yes No

B. AMBIS Sequence number for this requirement: 2129534 C. Total estimated dollar value of the requirement (including options, if applicable):

D. Period of performance, inclusive of options: from _______ to _______________ E. Project BackgroundOne of the goals of our lab is to perform antigenic characterization of the proteins/antigens that are used to vaccinate animals in the pre-clinical setting. Since it is essential to know if the proteins produced in house at the VRC are in the correct conformation, so that they can induce desired antibody response when vaccinated in animals, we perform antigenic characterization assays , which is also a way of quality control and antigenic analysis between different lots of the proteins produced. In order to do so, we screen the proteins (antigens) against a large panel of well characterized antibodies on the MSD platform and measure the binding data of the antigen to antibodies.

Humoral response is also very important along with cell mediated immune response to provide protection by our immune system against a pathogen. One of the basic immunological assay to test if a vaccine has induced any humoral response is to test the binding antibody titers against the specific vaccine insert. To perform this test, the most common method is ELISA (Enzyme Linked Immuno-Absorbent Assay). With the advancements in the technology, Meso Scale Discovery has developed a platform with more sensitivity and dynamic range than a traditional ELISA. This platform enables us to obtain binding data of antibodies against vaccine inserts/proteins in a very highly-reproducible format and enables to obtain consistent date of antigens against a large panel of antibodies in a very robust and controlled manner. The three plate types are for biotin coated antigens and unbiotinylated antigens. All three platforms are beneficial for current and upcoming projects.

F. Description of the supplies/services to be purchased Complete common generic identification of the item required.

MULTI-ARRAY 96 Plate Pack (100 Plates), Cat # L15XA-6 (x3) MA6000 384 SA Plate Pack (120 Plates) (X2) U-PLEX Development Pack, 10-Assay Sector Plate (25 Plates) (x4)

Name of manufacturer, producer, or distributor Meso Scale Discovery

1601 Research Boulevard Rockville MD 20850 +1 (301) 990-2776, Fax: +1 (301) 990-2776 (Maryland, USA)

Any other information necessary to describe the item required.

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

41 USC 3304(a)(1) a n d F A R P a r t 6 . 3 0 2 - 1 : Only one responsible source / Brand Name F A R P a r t 8 . 4 0 5 - 6 : Federal Supply Schedule (FSS), limited competition / Brand Name

Important Note: The statutory authority listed below will rarely ever be used in NIH. Before selecting this authority, please ensure that you have read and understood the citation and discussed it with the cognizant Contracting Officer.

41 USC 3304(a)(5) a n d F A R P a r t 6 . 3 0 2 - 5 : Authorized or required by statute / 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.

MSD platform with the principle of electrochemiluminescence improves sensitivity and dynamic range of the assay compared to traditional ELISA. Electrochemiluminescence detection uses labels that emit light when electrochemically stimulated. Background signals are minimal because the stimulation mechanism (electricity) is decoupled from the signal (light). Labels are stable, non-radioactive and offer a choice of convenient coupling chemistries. They emit light at ~620 nm, eliminating problems with color quenching. Multiple excitation cycles of each label amplify the signal to enhance light levels and improve sensitivity. MSD platform also enables the multiplexing technology (e.g. U-Plex), allowing to test upto 10 analytes in a single well if required. This dramatically increases the throughput of the assay and also eliminating the plate to plate variation.

V . Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable

Price reasonableness determination will be included in the acquisition file.

VI. Certification This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support my request (for the requestor) and approval (for the CO) of is accurate and complete.

Official Name & Title Signature Date