Notice of Intent to Award a Sole Source Contract to IRUBIS GmbH
Closed Special Notice Posted
- Solicitation number
- FDA-133409
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 334516 Analytical Laboratory Instrument Manufacturing
- Place of performance
- Silver Spring, Maryland 20993, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Food and Drug Administration issued a notice of intent to award a sole-source firm-fixed-price commercial purchase order to IRUBIS GmbH for a MONIPA_1 Protein Concentration Analyzer, with a June 15, 2026 deadline for capability statement submission. The sole-source justification rests on FAR 6.302-1: IRUBIS GmbH is the only responsible source capable of meeting agency requirements, as the analyzer uniquely integrates with the FDA's existing PAK BioSolutions downstream continuous purification platform and closed-loop mechanistic chromatography control environment. Market research determined that no alternative analyzers provide equivalent integration and real-time data exchange without requiring substantial redesign, revalidation, software redevelopment, system engineering modifications, and requalification of the existing process-control environment, all of which would cause unacceptable schedule delays. The procurement is conducted under simplified acquisition procedures for commercial products (FAR Part 12) and applies NAICS code 334516 (Analytical Laboratory Instrument Manufacturing). Interested firms may submit capability statements to Janice Heard (janice.heard@fda.hhs.gov) by June 15, 2026. The FDA retains sole discretion to compete the requirement based on submitted responses.
Notice text
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.
Files
| File | Type | Posted |
|---|---|---|
| Notice of Intent to Sole Source.docx | DOCX document |
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