SOW-CDER-2026-133117-SAM Posting.pdf

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FDA-RFQ- BioProfile FLEX2 Parts and Components-Brand Name or Equal
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CDER-2026-133117
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Statement of Work Summary

This is a Statement of Work (SOW) for the procurement of operational parts and consumables for three Nova BioProfile Flex 2 instruments used by CDER for upstream biomanufacturing research. The instruments are integrated with microbioreactor and automated sampling systems to enable precise cell culture monitoring and analysis without manual data collection. The contractor must provide brand name or equivalent compatible parts that meet NOVA BIOPROFILE FLEX 2 specifications and establish a delivery schedule to maintain operational capabilities due to material expiration risks.

The deliverables consist of specified quantities of parts and consumables across four delivery windows: within 7 days of award, 90-120 days post-award, 180-210 days post-award, and 270-300 days post-award. Items include pH/Gas MicroSensor cards (10 units per delivery), Chemistry MicroSensor cards (10 units per delivery), reference sensors, calibrator cartridges, reagent cartridges, calibration standards, reference solutions, micro tubes, quality control cartridges, shutdown cartridges, troubleshooting kits, cleaning solutions, and external tubing sets. The vendor is responsible for all shipping and handling costs above the contract amount and must contact the Contracting Officer (COR) prior to shipping to ensure receipt capability and provide tracking numbers. All deliveries are directed to Erica Berilla at CDER's Advanced Manufacturing Research Facility in Silver Spring, Maryland (Building 52/72 RM 2232).

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