Cryogenic Storage of cGMP Grade Cell Banks
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 Centers for Disease Control and Prevention (CDC) has issued a Notice of Intent to Sole Source for Cryogenic Storage of cGMP Grade Cell Banks. The CDC intends to award a firm fixed-price purchase order to BioReliance Solutions for the continued, uninterrupted storage of critical cell banks. While this is a sole source intent, small businesses are invited to submit capability statements. Responses are due May 22, 2026, at 3 PM EST.
Purpose & Scope
This acquisition ensures the continued cGMP-compliant cryogenic storage, maintenance, and secure management of CDC-qualified Master Cell Banks (MCBs) and Working Cell Banks (WCBs) for Vero, MDCK, and Expi293F cells. These cell lines are essential for developing seasonal and pandemic influenza CVVs. The contractor must provide validated, continuously monitored liquid nitrogen or colder cryogenic systems, ensuring long-term viability, integrity, and compliance with FDA regulations and cGMP requirements. The service must support current and future programmatic needs, maintaining traceable and accessible cell banks for vaccine manufacturing.
Contract Details
- Type: Firm Fixed-Price Purchase Order (Sole Source)
- Duration: Base year + four 12-month option years
- NAICS: 493120 Cold Storage Locker Services
- FAR Part: FAR Part 13 – Simplified Acquisition Procedures, Subpart 13.106-1(b)(1)
- Set-Aside: None (Notice of Intent to Sole Source)
Justification for Sole Source
The justification highlights that BioReliance is the only vendor capable of providing uninterrupted cGMP-compliant cryogenic storage for CDC's existing qualified cell banks without requiring physical transfer. Transferring these cell banks poses significant risks, including damage, contamination, loss of viability, temperature excursions, and disruption of the chain of custody, as advised against by FDA guidance. Such a transfer would also incur unbudgeted costs and increase regulatory and operational risks. Market research, including reviewing other vendors (ATCC, Charles River Laboratories, Thermo Fisher Scientific), confirmed that none could meet the specific need to avoid transfer while maintaining cGMP compliance and data continuity.
Response & Deadline
This notice is not a request for competitive quotes. However, any available small businesses (e.g., 8(a), service-disabled veteran owned, HUBZone, small disadvantaged, veteran-owned, and women-owned small businesses) may submit a written capability statement demonstrating their ability to perform the requirement. A determination to compete this award is solely at the Government's discretion. Capability statements are due by May 22, 2026, at 3 PM EST. Contact: Debra Baker, Contracting Officer, via email at xvv9@cdc.gov.