Notice of Intent to Award a Sole Source Contract to IRUBIS GmbH
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The Food and Drug Administration (FDA) intends to award a Sole Source firm-fixed price commercial Purchase Order to IRUBIS GmbH for a MONIPA_1 Protein Concentration Analyzer. This action is based on the unique integration capabilities of the analyzer with FDA's existing systems. Firms believing they can meet the requirements must submit a capability statement by June 15, 2026.
Opportunity Details
The FDA plans to acquire a MONIPA_1 Protein Concentration Analyzer from IRUBIS GmbH, located in Munchen, Bavaria, Germany. This is a Special Notice indicating an intent to award a sole source contract under the authority of FAR Part 6.302-1, citing only one responsible source. The acquisition will use simplified acquisition procedures in accordance with FAR Part 12 for commercial products.
Scope of Requirement
The primary requirement is the purchase of the MONIPA_1 Protein Concentration Analyzer. A critical aspect of this acquisition is the analyzer's ability to seamlessly integrate with the FDA's existing PAK BioSolutions downstream continuous purification platform and its associated closed-loop mechanistic chromatography control environment. The system must provide native interoperability between hardware components, process-control interfaces, and predictive modeling inputs to avoid substantial redesign, revalidation, operational disruption, or unacceptable schedule delays.
Rationale for Sole Source
IRUBIS GmbH is identified as the sole manufacturer of the MONIPA_1 Protein Concentration Analyzer. Market research did not identify any alternative analyzers capable of providing the equivalent integration and data exchange required for the FDA's specialized platform.
Contract & Timeline
- Contract Type: Firm-fixed price commercial Purchase Order (PO)
- NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing
- Set-Aside: Sole Source (No Set-Aside)
- Response Due: June 15, 2026, by 5:00 PM ET
- Published: June 1, 2026
- Place of Performance: Silver Spring, MD, United States
Submission & Evaluation
This notice is not a request for competitive quotes. However, firms that believe they can meet the stated requirements must submit a capability statement to the Contracting Officer, Janice Heard (janice.heard@fda.hhs.gov), by the response date. The Government will review submitted responses to determine if any other source can satisfy the agency's needs. The Government reserves the discretion not to compete this requirement based on the responses received.