Name | Type | Posted | Actions |
|---|---|---|---|
Sole Source Justification- CryoStorage1.pdf | May 13, 2026 |
Cryogenic Storage of cGMP Grade Cell Banks
Contact and place of performance
Debra Baker
Rockville, MD 20850
USA
This is a notice of intent to sole source for cGMP cell bank storage. This notice is not a request for competitive quotes. BioReliance Solutions is the service provider. However, any available small businesses (e.g., 8(a), service-disabled veteran owned small business, HUBZone small business, small disadvantaged business, veteran-owned small business, and women-owned small business) as stated herein may submit a writ...
View moreThe scope of this contract is the continued cryogenic storage and maintenance of CDC’s qualified cell banks under cGMP conditions. The contractor shall store the designated Master Cell Banks (MCBs) and Working Cell Banks (WCBs) for the Vero, MDCK, and Expi293F™ cell lines in validated continuously monitored liquid nitrogen or colder cryogenic systems. The contractor shall ensure long-term viability and integrity throughout the period of performance.
The overall objective is to maintain uninterrupted, regulatory-compliant cryostorage services for multiple CDC cell substrates, including Vero, MDCK, and Expi293F™ cell lines, all of which are essential for generating seasonal and pandemic influenza CVVs. The Contractor shall ensure compliance with all applicable FDA regulations, cGMP requirements, provide secure, monitored, and validated cryogenic storage conditions, security controls, and documentation standards necessary to preserve material integrity and support FDA-regulated vaccine manufacturing processes. The contractor must be capable of supporting both current and future programmatic needs, ensuring that CDC’s characterized and qualified cell banks remain viable, traceable, and immediately accessible for vaccine manufacturing workflows.
This acquisition is being conducted using policies unique to the Federal Acquisition Regulation (FAR) Part 13 – Simplified Acquisition Procedures, Subpart 13.106-1(b)(1), For purchases not exceeding the simplified acquisition threshold (SAT),which allows contracting officers to solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements.
Only one award will be made as a result of this notice. This will be awarded as a firm-fixed price purchase order.
The period of performance for this requirement will be a Base year and four 12 months option years. The North American Industry Classification (NAICS) code for this acquisition is 493120 Cold Storage Locker Services,(www.census.gov/naics
This will be the only notice of the Government's intent to solicit, negotiate, and award to one source to satisfy this requirement. The Government plans to award a contract for this requirement within 15 days of this notice.
Comments to this announcement, referencing this posting number, may be submitted to the CDC, Office of Acqusition Services (OAS), prior to the closing date specified in this announcement, to the attention of Debra Baker, Contracing Officer via email to [email protected] by May 22, 2026 at 3pm EST.
The Centers for Disease Control and Prevention (CDC) intends to award a firm-fixed price purchase order to BioReliance Solutions for the continued cGMP-compliant cryogenic storage and management of four Influenza Division cell banks. This requirement, identified by solicitation number 000HCJCB-2026-98842, supports the National Center for Immunization and Respiratory Disease (NCIRD) by ensuring the long-term viability of Master Cell Banks and Working Cell Banks for Vero, MDCK, and Expi293F cell lines. These biological materials are essential for generating seasonal and pandemic influenza Candidate Vaccine Viruses. This acquisition is categorized under NAICS 493120 Refrigerated Warehousing and Storage and PSC AJ13 GENERAL SCIENCE & TECHNOLOGY R&D SVCS; GENERAL SCIENCE & TECHNOLOGY; EXPERIMENTAL DEVELOPMENT.
The scope of work includes the maintenance of designated cell substrates in validated, continuously monitored liquid nitrogen or colder cryogenic systems at a facility in Rockville, MD. The contractor must ensure compliance with all applicable FDA and cGMP regulations, providing secure monitoring and documentation necessary to preserve material integrity and support regulated vaccine manufacturing workflows. The performance period is structured as a one-year base period followed by four 12-month option years.
This notice of intent to sole source is issued under FAR Part 13.106-1(b)(1) for purchases not exceeding the simplified acquisition threshold. Although the government does not intend to issue a competitive solicitation, small businesses may submit written capability statements by May 22, 2026, for the CDC to determine if the award should be competed. The notice includes one attachment, a Sole Source Justification, and designates Debra Baker as the primary point of contact.
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