Sole Source Justification- CryoStorage1.pdf

JUSTIFICATION FOR SOLE SOURCE PROCUREMENT (OPEN MARKET OR GSA)

UNDER $250,000

Sole source acquisitions may be used on a limited basis and only when the Contracting Officer’s Representative (COR)/Program Official has provided sufficient justification and the Contracting Officer has determined that the circumstances warrant such action. The content for a justification must contain detailed facts and rationale to justify the sole source acquisition. Soliciting from a single source must be done in accordance with FAR 13.106-1(b) or 8.405-6. At a minimum, the following information must be included:

Identification of Program Office, Contracting Activity, and Proposed Requirement, Justification and Program Office Certification:

A. Program Office:

National Centers for Immunization and Respiratory Diseases Influenza Division 1600 Clifton Rd., NE Bldg. 24, 7th floor Centers for Disease Control and Prevention Atlanta, GA 30333 Mailstop A-20

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch OAS Branch 3

C. Identification of Requirement:

1. Nature of Action to be Approved by Contracting Officer:

a. Sole source acquisition of: cGMP-grade Regulated Cryogenic Storage of six (6) Cell banks for a year, with optional years for each bank for four (4) additional years.

b. Procurement Request (PR) Number (if available): 000HCJCB-2026-98842

2. Proposed Vendor and Estimated Procurement Amount (if available):

a. Proposed Vendor: BioReliance

b. Estimated Procurement Amount: $

3. Is the requirement on GSA Schedule? ☐ Yes ☒ No

If yes, provide schedule number:.

Rev. 5/14/19

D. Justification:

1. The justification for this non-competitive action is:

☒ In accordance with FAR 13.106-1(b)(1), “only one source [is] reasonably available” which states that, “For purchases not exceeding the simplified acquisition threshold. (i) Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization). (ii) Where a single source is identified to provide a portion of a purchase because that portion of the purchase specifies a particular brand-name item, the documentation in paragraph (b)(1)(i) of this section only applies to the portion of the purchase requiring brand-name item. The documentation should state it is covering only the portion of the acquisition which is brand- name.”

☐ Urgency ☐ Exclusive licensing agreements/Proprietary data ☐ Brand name required ☐ Industrial mobilization ☒ Other (e.g., compatibility, space issues, continuity, compatibility, etc.)

☐ In accordance with FAR 8.405-6 “Limiting Sources” which states that, “the only circumstances that may justify the action are – (A) An urgent and compelling need exists, and following the procedures would result in unacceptable delays; (B) Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; or (C) In the interest of economy and efficiency, the new work is a logical follow-up to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original BPA must not have been previously issued under sole-source or limited-sources procedures.”

☐ Urgency ☐ Only One Source ☐ Logical Follow Up ☐ Brand name required

2. Other facts supporting sole source procurement:

a. What can this product/service do that other products/services cannot do?

The current vendor is the only vendor that can provide uninterrupted cGMP-compliant cryogenic storage for the CDC’s existing qualified Vero, MDCK, and Expi293F™ Master and Working Cell Banks without requiring physical transfer of the banks. FDA guidance does not support and advises against the transfer of qualified production cell banks, except when necessary, due to the significant risks of loss, contamination, shipping delays, or deviation events during transport. Some of the identified risks and effects on cellls transported between facilities are:

• Thermal Stress and injury

• Metabolic and Biological Alterations

• Physical Damage to vials or bags

• Decreased shelf life

Either of the listed actions may and can reduce viability and recovery of cells stored if not properly transported. In order to eliminate these risks due to transporting the cells, it may be more advantageous to the government to retain storage of NCIRD cells at the current facility.

The current vendor is the only vendor that currently maintains these specific banks, with established chain-of-custody, storage histories, environmental monitoring logs, and cGMP documentation already in place.

The Program Office conducted market research to identify likely potential and capable offerors. Research included reviewing vendor capability statements, public catalogs, and online technical literature from major providers of regulated biological storage services.

Catalog and website reviews were conducted for BioReliance Charles River Laboratories, Thermo Fisher Scientific, and ATCC, all of which advertise cell banking or cryogenic storage capabilities.

In addition, Program staff relied on personal knowledge and experience within FDA-regulated manufacturing environments, including prior work with cGMP and GLP cell banks and familiarity with the major U.S. providers in this space. Internal CDC SMEs were consulted to validate vendor capabilities and regulatory constraints. External industry contacts were also consulted to confirm the limited number of U.S. providers capable of storing cGMP-qualified cell banks.

The Program Office also reviewed entries in the Government Contract Directory (contractdirectory.gov) using multiple relevant search terms (“cryogenic,” “biorepository,” “GMP,” “cell bank,” “liquid nitrogen”) and found no alternative vendors offering the specific cGMP-regulated cell bank storage needed for this requirement. Identified entries were either university repositories not operating under cGMP, organizations focused on testing rather than long-term storage, or facilities outside the United States.

Although the Program Office identified four capable U.S. commercial vendors—BioReliance, ATCC, Charles River Laboratories, and Thermo Fisher Scientific selecting any vendor other than the incumbent would require the physical transfer of the existing cGMP-qualified cell banks, and would introduce unnecessary risk, cost, and program disruption. Accordingly,

b. What other products/services were considered, and why did they not meet the need?

Market research identified other U.S. vendors capable of offering cGMP-grade cryogenic storage services: ATCC, BioReliance, Charles River Laboratories, and Thermo Fisher Scientific. All are large, reputable businesses capable of storing biological materials in liquid nitrogen systems. However, the requirment of having to transfer all six cell banks to a new location would be high risk and not conducive to the FDA’s advice against moving the cells to a new location.

Each alternative was rejected for the following reasons:

1) FDA guidance discourages and advises against transfer of production and qualified cell banks because transfer introduces significant risk of damage, contamination, loss of viability, or temperature-excursion events.

2) Continuity of the chain of custody would be disrupted, requiring new intake, documentation, and potential requalification steps at the receiving vendor.

3) Additional unbudgeted costs would be incurred by CDC,

4) Each alternative increases regulatory and operational risk .

While ATCC, CRL, and Thermo Fisher are capable, none meet the Government’s need to avoid unnecessary transfer, maintain uninterrupted cGMP compliance, preserve continuity of storage data, and eliminate avoidable risk to critical CDC materials. Therefore there is only one source reasonably available to fulfill the requirement without compromising cell-bank integrity, regulatory compliance, or cost-efficiency.

3. Program Office efforts to seek potential offerors:

In addition, transferring cGMP-grade cell banks would result in high unplanned costs to CDC including labor hours for release coordination, cGMP-grade packaging, specialized shipping arrangements, and intake/qualification at the receiving facility.

These costs and time introduce unnecessary risk to irreplaceable biological materials. The current vendor’s service uniquely avoids these costs and risks.

E. Program Office Certification:

I have reviewed this sole source justification and certify the justification is true and accurate to the best of my knowledge and adequate to support other than full and open competition.

Center/Institute/Office COR/Program Official Name/Title: CDC/NCIRD/ID; Irene Chery; MGMT and Program Analyst

Center/Institute/Office COR/Program Official Signature:

Certification Date: April 30, 2026

F. Contracting Office Certification:

I have fully relied on the information provided herein and hereby certify that this justification is accurate and complete to the best of my knowledge and belief:

Contracting Officer Name: DEBRA A. BAKER

Contracting Officer Signature:

Certification Date: May 8, 2026 the current vendor was determined to be the only reasonably available source to meet the Government’s needs without the transfer of materials.