SAM #FDA-133409

FDA Sole Source Procurement of IRUBIS MONIPA_1 Protein Concentration Analyzer

The Food and Drug Administration (FDA) has announced its intent to issue a sole source, firm-fixed price contract to IRUBIS GmbH for a MONIPA_1 Protein Concentration Analyzer. - The procurement is for one MONIPA_1 Protein Concentration Analyzer, manufactured by IRUBIS GmbH. - This analyzer is uniquely compatible with the FDA's existing PAK BioSolutions downstream continuous purification platform and closed-loop mechanistic chromatography control environment. - The integration allows real-time data exchange and does not require system redesign or revalidation, making IRUBIS GmbH the only identified vendor able to meet these requirements. - The acquisition falls under NAICS code 334516 (Analytical Laboratory Instrument Manufacturing). - The place of performance is Silver Spring, Maryland, with the contracting office located in Rockville, Maryland. - No set-aside is specified, and no competing products or vendors are listed in the notice. - The opportunity is described as a Notice of Intent to Sole Source, with further details available in the attached document.

Description

The Food and Drug Administration (FDA) intends to award a Sole Source firm-fixed price commercial Purchase Order (PO) to IRUBIS GmbH, Bayerstrasse 85A, Munchen, Bavaria 80335, Germany for the Purchase of a MONIPA_1 Protein Concentration Analyzer. 

Please review the attached Intent to Sole Source FDA-133409 document for more information.

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