A05_Justification for Under SAT_Final.pdf

This is a Decision to Restrict Competition under the Simplified Acquisition Threshold document issued by the United States Department of Agriculture.

The document authorizes a single-source procurement under requisition number 1170246 for the Animal Plant Health Inspection Service (APHIS), Veterinary Services (VS), Center for Veterinary Biologics (CVB). The contracting activity is APHIS, Marketing and Regulatory Programs Business Services (MRPBS), Acquisition and Asset Management Division (AAMD). The acquisition involves procuring a SoloVPE Plus spectroscopy instrument from Repligen Corporation (located at 41 Seyon Street, Waltham, MA 02453; UEI: H9J9D228RFQ9). This equipment uses Slope Spectroscopy methodology to characterize samples through multiple absorbance data points at different pathlengths and is required for analyzing Monoclonal Antibody (mAB) products to ensure compliance with Virus, Serum, Toxin Act (VSTA) requirements. The justification for restricting competition is that Repligen is the sole manufacturer of the SoloVPE Plus and it is not available through any U.S. distributors. Market research confirmed no alternative sources or distributors exist. The CVB laboratory requires this specific equipment with identical testing capabilities to determine whether products are Pure, Safe, Effective, and Potent as mandated by the VSTA. The document is certified by Anna Dash, Microbiological Technician, and approved by Contracting Officer Kathy Melby, both dated August 19, 2026.