ProteinSimple Maurice Parts & Components

Background
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Product Quality and Research (OPQR) currently owns and operates a ProteinSimple CE-SDS/cIEF (Maurice) protein characterization and analysis system. This system offers high throughput capillary electrophoresis sodium dodecyl sulfate separation for size/purity and capillary isoelectric focusing for isoelectric point determination via assay cartridges. Size/purity and charge are critical quality attributes (CQAs) of biotechnology products assessed during biomanufacturing. The current workload of this instrument requires that it always perform accurately, which requires regular replacement of operational parts, components, and peripherals that are BRAND NAME ONLY to Bio-Techne ProteinSimple and compatible with OPQR’s ProteinSimple CE-SDS/cIEF (Maurice) system.

Work Details
The Contractor shall provide the products meeting the requirements as in section 3. The Contactor shall provide the following items required for continued maintenance and operation of the instrument, including calibration and quality control testing: Maintenance/Operational parts and components such as Maurice Turbo CE-SDS Application Kit, Maurice CE-SDS Conditioning Solution 1, Maurice CE-SDS PLUS, 1x Sample Buffer, Maurice CE-SDS Separation Matrix, Maurice CE-SDS Wash Solution, Maurice cIEF pI Marker - 4.05, iCE Electrolyte Kit, 0.5% Methyl Cellulose Solution, Maurice cIEF System Suitability Kit, Maurice cIEF pI Marker - 8.40, Maurice 96-Well plates, Maurice cIEF pI Marker - 5.85, Maurice cIEF pI Marker - 10.17, Maurice cIEF Fluorescence Calibration Standard, SimpleSol Protein Solubilizer for cIEF application, Maurice CE-SDS IgG Standard, Maurice CE-SDS Orange Pressure Caps, Maurice Glass Reagent Vials, 2 mL, Maurice CE-SDS Running Buffer - Bottom, Maurice CE-SDS Running Buffer - Top, Maurice CE-SDS Conditioning Solution 2, Maurice CE-SDS 25x Internal Standard, Maurice cIEF 500 mM Arginine, 1% Methyl Cellulose Solution, Maurice Cartridges for cIEF application and Maurice CE-SDS PLUS Cartridge.

Period of Performance
All parts and components shall be delivered during SEPTEMBER 2024 AND NO LATER THAN SEPT 30TH, 2024.

Place of Performance
Contractor shall provide FOB Destination shipping, handling and inside delivery to CDER’s facilities at the address provided: FDA White Oak Campus Bldg 52/72 Rm 2248 10903 New Hampshire Ave Silver Spring MD 20993