Procurement of Multitron HT Incubator
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 Division of Product Quality Research (DPQR) at the Advanced Manufacturing Research Facility (AMRF), is conducting market research through a Sources Sought Notice for the Procurement of a Multitron HT Incubator system. This system is required to support mammalian cell culture at production-relevant volumes, addressing current equipment limitations. Interested vendors must submit capability statements by April 17, 2026, at 12:00 PM ET.
Purpose & Scope
This market survey aims to identify vendors capable of providing a commercially available incubator shaker system that supports mammalian cell culture under controlled environmental and agitation conditions. The FDA requires this equipment to enhance capacity and performance for large-volume cultures (e.g., 5-liter flasks) and existing Chinese hamster ovary (CHO) suspension culture processes. The requirement is limited to equipment and associated services, excluding process development or modification of existing protocols.
Key Requirements
The desired system must be a triple-stack incubator shaker with independent control for temperature, CO₂, humidity, and orbital shaking in each unit. It must be compatible with 5-L Erlenmeyer shake flasks and existing CHO suspension culture processes. Essential features include adjustable orbital shaking, integrated humidity and CO₂ control, UV sterilization, a dark observation window, a cable passthrough port, and UL certification. Vendors must also provide IQ/OQ documentation, on-site installation, and training for 1-3 end-users. The solution must be commercially available and functionally equivalent to specified performance standards without requiring changes to existing protocols or retraining.
Submission Details
This is a Sources Sought Notice for market research only; it is not a solicitation, and no contract will be awarded from this notice. No reimbursement will be made for submission costs. Vendors are requested to submit a capability statement, not exceeding 10 pages, in PDF or Microsoft Word format, demonstrating their ability to meet the technical requirements.
Eligibility & Information Requested
Responses are appreciated from both small and other than small businesses. The relevant NAICS Code is 334516 (Analytical Laboratory Instrument Manufacturing) with a small business size standard of 1,000 employees. Vendors should identify their company name, address, Cage Code, UEI, recommended NAICS code, company size, socio-economic status, any GSA Schedule or government-wide contracts held, and domestic manufacturing status. Technical specifications for the proposed solution should also be included.
Deadline & Contact
Capability statements are due by April 17, 2026, at 12:00 PM ET. Submissions should be emailed to Reagan.Davis@fda.hhs.gov with the subject line: "Sources Sought Notice Number: SSN_ CDER-2026-133237 Multitron HT Incubator."