Rocking Bioreactor System
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The U.S. Food and Drug Administration (FDA), specifically the Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Pharmaceutical Quality Research (OPQR), is soliciting proposals for a Rocking Bioreactor System. This Firm-Fixed Price requirement aims to replace aging equipment and support advanced bioprocessing research and development activities. The opportunity is being competed as Unrestricted / Full and Open Competition.
Scope of Work
The requirement is for one (1) Rocking Bioreactor System, which must meet specific technical requirements for its Primary Rocker Unit, Gas Mixer - Cellbag Control Unit (CBCU), Peristaltic Pump, Instrument Control Package, Bag Sensor Adaptor, WorkStation software, and Tube Kit. The system must be capable of running fed-batch and perfusion cultures using single-use cell bags with full environmental control. Key technical specifications include ranges for rocking speed, angle, weight measurement, temperature control, gas flow, CO2/O2 control, pH and DO measurement, and flow rate. The contract also includes installation by certified technicians, training, and one-year maintenance support. Delivery is required within 60 days of contract award.
Contract & Timeline
- Contract Type: Firm-Fixed Price
- Set-Aside: Unrestricted / Full and Open Competition
- NAICS Code: 334516 - Analytical Laboratory Instrument Manufacturing (Small Business Size Standard: 1,000 employees)
- Place of Performance: Silver Spring, MD
- Proposal Due: June 12, 2026, by 1:00 PM Central Time
- Published Date: June 4, 2026
- Period of Acceptance: Prices must be held firm through September 30, 2026
Submission & Evaluation
Offerors must submit quotes/proposals via email to howard.nesmith@fda.hhs.gov. Submissions must include descriptive material demonstrating that the offered system meets all technical requirements for technical acceptability. Offerors must be registered and active in SAM.gov and include their Unique Entity ID (UEI). An Accessibility Conformance Report (ACR) based on the Voluntary Product Accessibility Template (VPAT) is required for items not in compliance with Section 508 standards. Evaluation will be based on the Lowest Price Technically Acceptable (LPTA) and responsible offeror, with the lowest priced offer being evaluated first.
Additional Notes
Price quotes are FOB Destination, inclusive of all shipping, handling, delivery, installation, and training charges. Any catalog number, manufacturer brand name, or proprietary description used in the solicitation is for descriptive purposes only and is not restrictive. Offerors are advised not to submit documents containing macros. The solicitation incorporates various FAR and HHSAR clauses by reference.