ProteinSimple Maurice consumables

The FDA's Center for Drug Evaluation and Research is conducting a market survey for consumables and materials supporting a ProteinSimple Maurice capillary electrophoresis system (model Maurice-OBM, serial number KF-1804) used in regulatory research on complex biopharmaceuticals, with responses due by 2:00 pm Central Time on July 24, 2026. This is a sources sought notice for market information only; no contract will be awarded from this announcement.

The government seeks ProteinSimple Maurice products or equivalent consumables—cartridges, reagents, and standards for assessing size and charge variants of therapeutic monoclonal antibodies, fusion proteins, enzymes, cytokines, and recombinant peptide drug products. Required items must meet five salient characteristics: system integration without hardware or software modifications; pre-assembled, fully enclosed glass capillary cartridges with integrated waste bins; precision detecting protein variants within pH 3.0 to 10.17; ISO 9001 and ISO 13485 certified manufacturing; and traceability documentation via Certificate of Analysis. Seventeen specific catalog items are listed.

Delivery is to the FDA/CDER White Oak Campus in Silver Spring, Maryland. The intended contract structure is Firm-Fixed-Price with a Base Period (delivery within 30 days of award, funded by FY26 funds) and three option quantities at 90-day, 180-day, and 270-day post-award intervals. The notice targets small businesses under NAICS 325413 (In Vitro Diagnostic Substance Manufacturing) with a 1,250-employee size standard, though other vendors are encouraged to respond. Responses must include business information, past performance data within the last three years, technical specifications, descriptive literature, GSA Schedule or other government contract information if applicable, and place of manufacture for Buy American Act compliance review. Submit to suzanne.martella@fda.hhs.gov by July 24, 2026 (Reference: 75F40126SSN13285).