Notice of Intent to Award a Sole Source Contract to IRUBIS GmbH

The Food and Drug Administration (FDA) intends to award a Sole Source firm-fixed price commercial Purchase Order to IRUBIS GmbH for the purchase of a MONIPA_1 Protein Concentration Analyzer. The analyzer is uniquely capable of integrating with the FDA's existing PAK BioSolutions downstream continuous purification platform and associated closed-loop mechanistic chromatography control environment. The FDA did not identify any alternative analyzers capable of providing equivalent integration, real-time data exchange, and compatibility with the installed configuration without substantial redesign, revalidation, operational disruption, and unacceptable schedule delays. • The contract is for the purchase of a MONIPA_1 Protein Concentration Analyzer. • The analyzer must be able to integrate with the FDA's existing PAK BioSolutions downstream continuous purification platform. • The FDA did not identify any alternative analyzers that can provide equivalent integration and compatibility. • The contract is being conducted using simplified acquisition procedures in accordance with FAR RFO Part 12 for the acquisition of commercial products and commercial services.