Notice of Intent to Sole Source.docx
DOCX document 39 KB Posted
- Solicitation number
- FDA-133409
About this file
This is a Notice of Intent to Award a Sole Source Contract from the Food and Drug Administration (FDA) for the purchase of a MONIPA_1 Protein Concentration Analyzer. The FDA intends to award a firm-fixed price commercial Purchase Order to IRUBIS GmbH, located at Bayerstrasse 85A, Munich, Bavaria 80335, Germany. The acquisition is being conducted under simplified acquisition procedures for commercial products in accordance with FAR Part 12, with the sole source justification based on FAR 6.302-1, citing that only one responsible source exists and no other supplies or services will satisfy agency requirements. The NAICS code applicable to this action is 334516 (Analytical Laboratory Instrument Manufacturing).
The MONIPA_1 Protein Concentration Analyzer is uniquely capable of integrating with the FDA's existing PAK BioSolutions downstream continuous purification platform and its associated closed-loop mechanistic chromatography control environment. IRUBIS GmbH is identified as the sole manufacturer of this equipment. Market research determined that no alternative analyzers can provide equivalent integration, real-time data exchange, and compatibility with the installed system architecture without requiring substantial redesign, revalidation, operational disruption, and unacceptable schedule delays. Any alternative would necessitate significant software redevelopment, system engineering modifications, and requalification of the existing process-control environment. Interested firms may submit capability statements to Janice Heard at janice.heard@fda.hhs.gov no later than June 15, 2026, for consideration. The government retains sole discretion in determining whether to compete this requirement based on submitted responses.
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Notice of Intent to Award a Sole Source Contract
Notice of Intent to Award a Sole Source Contract to IRUBIS GmbH (FDA-133409) 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 in accordance with the authority under FAR RFO Part 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. The NAICS Code for this action is 334516–Analytical Laboratory Instrument Manufacturing industry. This acquisition is being conducted using simplified acquisition procedures in accordance with FAR RFO Part 12 for the acquisition of commercial products and commercial services.
IRUBIS GmbH is the only manufacturer of the MONIPA_1 Protein Concentration Analyzer. The MONIPA_1 Protein Concentration 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 existing system architecture relies on native interoperability between hardware components, process-control interfaces, and predictive modeling inputs. Market research 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. Use of another product would require significant software redevelopment, system engineering modifications, and requalification of the existing process-control environment."
This notice is not a request for competitive quotes. Any other firms desiring consideration must fully identify their interest and capability of meeting the requirements by submitting a capability statement to Janice Heard at janice.heard@fda.hhs.gov no later than June 15, 2026. Any response shall undergo review to determine if it can meet the requirements. A determination by the Government not to compete this proposed requirement based upon a response to this notice is solely within the discretion of the Government.
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