JA 2026733.docx

Justification for Other than Full and Open Competition Project Title: Semi-automated antibody purification

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. Project Background

The Vaccine Research Center (VRC) is peforming critical work in pandemic response to SARS-CoV-2 infection (i.e., COVID-19). These efforts include the discover antibodies targeting SARS-CoV-2 antigens as potential treatments, in diagnostics and reagent use. In addition, the VRC is analyzing SARS-CoV-2 specific immune responses following infection and vaccine induced immune response. This project will use dozens of customized proteins to analyze immune responses and isolated antibodies. In addition, thousands of unique antibodies are expected to by identified, expressed and purified for the analysis. This work is needed critically and urgently to support the pandemic response efforts of the VRC to SARS-CoV-2.

B. Project Description This project seeks to apply high-throughput protein expression and purification methodologies. The project will use seek to use automation methods to increase the throughput and due to needs to minimize staff requirements due to the current and expected needs of social distancing surrounding COVID-19. Automation solutions should be able to perform magnetic separation of protein and antibody expression and purification in a high-throughput capacity for volumes between 5-50mL, be able to process at least 12 samples in parallel and complete the purification and regeneration of magnetic bead reagents in less than one hours time. This should have a easy to use computer interface and complete it’s tasks with miniml user interaction. The system must accommodate both 15 and 50 mL tubes, have a closed environment with air filters to clean air and must maintain a positive pressure airflow. The instrument and any tubing should be able to be treated to remove contaminants such as endotoxins using standard solutions like 0.1Molar sodium hydroxide. Due to constraints on space, systems will need to fit within a width and length of 24x24 inches.

III. Identification of the statutory authority permitting other than full and open competition (SELECT ONE) ☐ 41 USC 253(c)(1) and FAR Part 6.302-1: 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) GenScript USA Inc.

860 Centennial Ave Piscataway, NJ 08854 B. Describe why only the requested supply/service will meet the government’s needs GenScript's AmMag SA automates the protein or antibody purification using magnetic beads and is capable of using 6-well deep well culture plates, 15ml or 50 mL tubes. In combination with magnetic beads, the system offers high throughput and high capacity protein and antibody purification from up to 12 samples and volumes of 5-50 mL. The typical cycle time of the system is 40 minutes or less and if used with AmMag protein A magnetic beads, the system is able to reuse beads by performing an automated cleaning protocol. The purification and bead cleaning process is typically completed in less than one hour and thereby reduces costs and increases throughput. It’s ability to use magnetic beads that are added directly to cell culture media saves time on additional upstream steps that are required in other systems and method and decrease the amount the time and effort required prior to purification. This savings on pre-processing time allows us to reduce the amount of staff and time required to process samples. The sytem’s has a filtered self-contained air system that maintains positive pressure and the tubing can be cleaned using 0.1 M NaOH to help eliminate contaminants like endotoxin. The dimensions of the system is 21.5 x 20.3 x 21.5 inches and therefore fits within the designated space requirements.