Attachment 3 - JA Modified for FAR Part 13.501 Ambr 250 Bioreactor System_Redacted.pdf

This document is a Justification and Approval (J&A) for a sole source acquisition of an Ambr 250 High Throughput Bioreactor System for the Walter Reed Army Institute of Research (WRAIR). The procurement is for a new Firm Fixed Price commercial contract using simplified procedures, specifically for a Brand Name Ambr 250 High Throughput (12) Bioreactor system to support process development activities and facilitate the transition of products from research to Current Good Manufacturing Practices (cGMP) for Phase I clinical trials at the Pilot Bioproduction Facility (PBF).

The procurement includes system delivery, installation, qualification, site acceptance testing, training, and a 12-month warranty/support package. The requirement is sole-sourced to the Original Equipment Manufacturer (OEM), Sartorius Stedim North America Inc., as the Ambr 250 is identified as the only fully automated, high-throughput parallel bioreactor system with unique capabilities for small-scale working volumes and process transferability. The acquisition is set aside for small businesses, with a NAICS code of 334516, and is being conducted by the United States Army Medical Research Acquisition Activity (USAMRAA) under the Defense Health Agency.