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 of Munich, Germany, for the acquisition of a MONIPA_1 Protein Concentration Analyzer under Solicitation FDA-133409. This action is justified under FAR 6.302-1, as IRUBIS GmbH is the only responsible source capable of providing the MONIPA_1 analyzer, which is uniquely integrated with the FDA’s existing PAK BioSolutions continuous purification platform and closed-loop mechanistic chromatography control system. The equipment must enable real-time protein concentration measurement without requiring system redesign, revalidation, or operational disruption, making it non-interchangeable with any other commercially available product. The purchase is governed under FAR Part 12 as a commercial item acquisition, with no competition anticipated, and no small business set-aside provisions apply. The place of performance is designated as Silver Spring, Maryland, with the contract to be managed by the FDA’s office in Rockville, Maryland. The solicitation requires offerors to submit a capability statement via email to Janice Heard at janice.heard@fda.hhs.gov by June 15, 2026, with no formal page limits, formatting rules, or submission templates specified. No detailed pricing, line items, contract value, or payment instructions are included in the notice, as this is an intent to award prior to formal PO issuance. No packaging, marking, inspection criteria, delivery schedules, FOB terms, or special requirements such as security clearances, key personnel obligations, contract options, or organizational conflict of interest provisions are outlined, reflecting the streamlined nature of this commercial acquisition. IRUBIS GmbH’s UEI, CAGE code, size status, or socioeconomic certifications are not provided, nor are any representations or certifications from the offeror included in the documentation. Acceptance is expected to occur at the delivery site in Silver Spring, Maryland, with performance based on the analyzer’s seamless interoperability and functional compatibility with FDA systems. The NAICS code for this procurement is 334516, reflecting its classification under analytical laboratory instrument manufacturing.