How to bid on CryoStor CS10 bags for cell therapy at NIH

What the NIH is buying and why it matters

The National Institutes of Health (NIH) Clinical Center needs 80 bags of CryoStor CS10, 100 mL each. These bags are used for cryopreservation of FDA-regulated cell therapy products in clinical trials at the NIH Clinical Center in Bethesda, Maryland.

The NIH intends to award this purchase to BioLife Solutions on a sole-source basis. This is because the product is already validated for their regulated manufacturing processes. However, other businesses can submit a capability statement if they believe they can meet the requirement.

Key dates and what happens at the deadline

This is a Request for Information (RFI), not a request for quotes or proposals. The deadline for submitting capability statements is August 13, 2026, at 6:00 PM Eastern Time.

After the deadline, the Government will evaluate all received capability statements. The determination to not compete this requirement remains at the Government's discretion.

Who this opportunity suits

This opportunity is for firms that manufacture or supply CryoStor CS10, 100 mL bags, or an equivalent product that can meet the specific validation requirements for FDA-regulated cell therapy manufacturing processes. The relevant product service code is 6550 (In Vitro Diagnostic Substances, Reagents, Test Kits, and Sets) and the NAICS code is 325413 (In-Vitro Diagnostic Substance Manufacturing).

How to respond to this RFI

To access the original notice, click “View original source” above. If you land on the portal’s homepage, click the link again to go directly to the bid. You may need a free account to view documents, though this is not always required.

Capability statements must reference POTS 26-007655 and be submitted electronically. The point of contact for submissions is Shasheshe Goolsby, Team Leader, Hospital and Laboratory Support Division, Office of Acquisitions and Logistics Management, National Institutes of Health, via email at [email protected].

Tips for preparing a competitive response

Even though this is an RFI and an intended sole-source award, a strong capability statement can still be valuable. Clearly articulate how your product meets or exceeds the specific requirements mentioned, especially regarding validation for FDA-regulated manufacturing processes and existing Master Files.

Focus on demonstrating that your product is a direct equivalent or superior alternative to CryoStor CS10, and explain how it would avoid the revalidation costs, schedule delays, and potential impacts to patient care that the NIH has identified. Provide concrete evidence of your product's quality standards and regulatory approvals.