SAM #CDER-2026-133117

FDA CDER Solicits Nova Biomedical BioProfile FLEX2 Parts and Consumables for Biomanufacturing Research

The FDA's Center for Drug Evaluation and Research (CDER) is procuring operational parts and consumables for three Nova Biomedical BioProfile FLEX2 instruments used in biomanufacturing research. - Government Buyer: - U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) - Advanced Manufacturing Research Facility - OEM Highlight: - Nova Biomedical (manufacturer of BioProfile FLEX2 instruments and consumables) - Products Requested: - BioProfile FLEX2 consumables and parts, including: - MicroSensor Cards (pH/Gas and Chemistry, part numbers 57510, 57512; 10 each per phase) - Reference Sensors (pH/Gas and Chemistry, part numbers 57467, 57466; 1 each) - Calibrator and Reagent Cartridges (part numbers 58102, 58101; 8-10 each) - CDV Reagent Cartridges (part number 55297; 11 each) - Calibration Standards and Reference Solutions (part numbers 42437, 42439; 1 each) - Micro tubes (part number 59859; 1 box) - Auto QC Cartridges (pH/Gas and Chemistry, part numbers 56073, 57035; 5-7 each) - S-Line Probe Assemblies (part number 55288; 2 each) - Shutdown Cartridges (multiple types, part numbers 60608, 60610, 60611, 60612, 60613; 1-2 each) - Flowpath Troubleshooting Kit (part number 66287; 1 each) - Advanced Cleaning Solution (part number 63940; 1 each) - ESM Reagent Cartridge (part number 56227; 2 each) - ESM External Tubing Set (part number 59209; 1 each) - Unique/Notable Requirements: - All items must be new, unused, and not refurbished or grey market - Products must arrive with at least 75-80% of shelf life remaining - Items requiring refrigeration or classified as flammable must be shipped per manufacturer and DOT/IATA regulations - Offerors must be the manufacturer or an authorized reseller - One-year warranty from first use or installation acceptance - Delivery is phased over four intervals within approximately 10 months (7 days, 90-120 days, 180-210 days, 270-300 days post-award)

Description

Request for Quotation:  FDA-RFQ-CDER-2026-133117 BioProfile FLEX2 Parts and Components-Brand Name or Equal

Notice of Combined Synopsis/Solicitation – This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with part 12. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued.

Background – The Center for Drug Evaluation and Research (CDER) requires operational parts and consumables for three (3) currently owned Nova BioProfile Flex 2 instruments. To meet the purpose and objective of this requirement, a single Contractor shall provide the parts and components listed in the Statement of Work (SOW) that must be compatible with the corresponding three (3) NOVA BioProfile Flex 2 instruments:

Main FLEX2 instrument 1: Serial Number- T262230070C

Main FLEX2 instrument 2: Serial Number- T26817050C

External sampling module for instrument 2: T2761720PC

Main FLEX2 instrument 3: Serial Number- T26A200050C  

Please note Main FLEX2 instrument 2 has two serial numbers because it has an additional module added which has its own Serial Number. The offeror is also expected to adhere to the:

the established delivery times as expressed in Section 5.1 of the attached combined solicitation/synopsis the fullest extent practicable. Minimum Salient Characteristic  Requirements:

1. Compatibility is needed for three currently owned Nova BioProfile Flex 2 instruments as described in this Section (Section 5). The Contractor shall identify the following salient characteristics for BioProfile Flex-2 commercial parts and consumables or equal

2. Instrument identity: Manufacturer (Nova Biomedical), instrument name and model (BioProfile FLEX 2), and all three serial numbers of the government-owned instruments 3. Instrument function: Automated bioanalysis system for cell culture monitoring, measuring parameters such as pH, dissolved gases, metabolites, osmolality, and cell density  

4. Compatibility requirement: All parts and consumables supplied must be fully compatible with and functional in the Nova BioProfile FLEX 2 as configured at the FDA facility, without modification to the instrument

5. Quality standard: All items must be new, unused, and free from defects; grey market and refurbished products are unacceptable

6. Shelf life: All items must arrive with at least 75% to 80% of their total shelf life remaining upon delivery

7. Cold chain: Items requiring refrigeration or classified as flammable must be shipped and delivered in accordance with manufacturer specifications and applicable DOT/IATA regulations

8. Authorization: Offeror must be the manufacturer or an authorized reseller of the items quoted  

Place of Performance:

Food and Drug Administration

Attn: Erica Berilla

10903 New Hampshire Ave

Bldg. 52/72 RM 2232

Silver Spring, MD 20903

Period of Performance:

12 consecutive months commencing upon date of Award.

Please see the attached Statement of Work and Corresponding Justification for reference/utilization. Quotes are due by email on or before June 26, 2025, by 12:00 P.M. (Eastern Daylight Time) and should be sent to brandon.rafus@fda.hhs.gov.

View original listing