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 acquisition is sole-sourced to the Original Equipment Manufacturer (OEM), Sartorius Stedim North America Inc., and its authorized resellers, due to the system's unique capabilities. The procurement includes system delivery, installation, qualification, site acceptance testing, training, and a 12-month warranty/support package. The contract will be 100% Small Business set-aside, with a total of three 12-month option periods for service and maintenance. Market research conducted between August 2024 and April 2025 confirmed the Ambr 250 as the only fully automated, high-throughput 12 parallel bioreactor system with small-scale working volumes specifically designed for process development and optimization.