FAR-13-Limited-Sources-Justification-Less-Than-SAT-_Redacted - Final.pdf

This document is a Limited Source/Brand Name Justification form from the United States Department of Agriculture for a bioreactor control system. The National Bio and Agro-Defense Facility (NBAF) requires an Eppendorf BioFlo 320 instrument for production of recombinantly expressed proteins critical for the Foreign Animal Disease Diagnostic Laboratory's expanded diagnostic mission. The specific requirements include cell culture species flexibility (mammalian, insect, bacterial, and yeast), continuity of standardized protocols, seamless scaleup of production volumes, high input control and configurability, and compatibility with NBAF biosecurity policies.

Market research conducted by the agency included systems from Sartorius, Eppendorf, Cytiva, and MilliporeSigma, but determined that the Eppendorf BioFlo 320 is the only bioreactor control system meeting all their technical specifications. The instrument will support NBAF's goal of becoming a global resource for ISO17034 accredited reference materials and establishing a zoonotic disease diagnostic program, with the ability to produce reference materials for critical foreign animal diseases such as foot and mouth disease, African swine fever, and classical swine fever.