Justification and Approval_Signed_Redacted.pdf

JUSTIFICATION REVIEW DOCUMENT

FAR Part 12 Justification and Approval

Acquisition Of Commercial Products and Commercial Services Program/Equipment: Custom Commercial Aptamer Procurement for the U.S. Army Combat Capabilities Development Command Chemical Biological Center (DEVCOM CBC) located at Gunpowder, MD.

Authority: Title 41 United States Code (U.S.C.) §1901(e)(2) as implemented in Revolutionary Federal Acquisition Regulation Overhaul (RFO) 12.102 (b), sole source under the authority of the simplified procedures for commercial items.

Amount:

Individual preparing the Justification and Approval document.

Prepared by:

Contracting Officer:

Representatives within the organization with specific knowledge of the individual requirement (program/equipment, commodity, technology, and/or function) and the responsibility for acquiring the supplies or services described in the justification (e.g. Contracting Officer’s Representative (COR), depot commander, or senior program engineer) may represent the technical and requirements certifications.

Technical:

Requirements:

FAR Part 12 Justification and Approval

Acquisition Of Commercial Products and Commercial Services

1. Requiring Activity Department of War (DoW), U.S. Army Combat Capabilities Development Command Chemical Biological Center (DEVCOM CBC), Research & Development Directorate, 8567 Ricketts Pt Rd, Bldg E3549, Bay 4, Gunpowder, MD 21010.

Technical Specialization & Infrastructure:

Unique Cost and Yield Structure:

Justifications citing for less than full and open competition on a follow-on contract must corroborate (1) substantial duplication of cost that is not expected to be recovered through competition and/or (2) unacceptable delays in filling agency requirements:

These specific custom aptamer sequences are currently integrated into active DEVCOM CBC assay baselines and mission-support threat detection platforms.

Sourcing these reagents from an alternate vendor lacking Aptagen's verified dPAGE purification and sequence-verification protocols would invalidate existing analytical baselines. This would require an estimated 14 to 18 months of laboratory re-testing and over in duplicated labor and material costs to re-establish biological baseline costs that the Government cannot recover through competition.

Alternatives:

Conducting a Competitive Acquisition among General Oligo Vendors: This option is not acceptable.

Use of In-House Government Resources: This option is not acceptable.

Sourcing from Foreign Commercial Suppliers: This option is not acceptable.

Impact if not approved:

If this justification is disapproved, DEVCOM CBC will be unable to procure the custom, PAGE-purified aptamers required for ongoing chemical and biological defense research. This will cause an immediate work stoppage for active detection assay development programs, delaying national security threat-detection deployment milestones and stranding prior Government analytical investments, leading to a minimum program slip of 14 to 18 months and a waste of in un-recoverable historical labor.

7. Efforts to Obtain Competition In accordance with FAR Part 10, ACC-APG ECD posted a formal Sources Sought / Request for Information (RFI) Notice under Solicitation/Notice ID W911SR-26-X- 0008, titled "DEVCOM CBC Commercial Aptamer" on SAM.gov, with responses due July 31, 2026. The notice requested capability statements from industry to synthesize custom DNA, RNA, and peptide aptamers, provide laboratory QC, and package lyophilized products for ambient shipping.

Effective competition

Effective competition was not achieved through the RFI notice. A total of four (4) responses were received and evaluated by the technical Subject Matter Expert (SME). Only one respondent, Aptagen Labs, LLC, demonstrated the required technical capability, wet-lab facilities, and purification standards

Subcontracting competition:

Aptagen Labs, LLC confirmed in its RFI submission that it will perform 100% of the contract requirement in-house using its internal Chemical Synthesis and R&D laboratories, in compliance with FAR 52.219-14(c) (Limitations on Subcontracting).

Subcontracting opportunities are therefore not anticipated.

8. Actions to Increase Competition This action is a follow-on to standard simplified acquisition open-market delivery orders. DEVCOM CBC and ACC-APG ECD will continue to monitor the commercial biotechnology marketplace via scientific literature, trade conferences, and market surveys. Should new domestic vendors emerge with dedicated aptamer synthesis, dPAGE purification, and guaranteed yield capabilities matching Department of War standards, future requirements will be competed.

9. Market Research Market research was conducted by , Biologist, DEVCOM CBC, between May 14, 2026, and August 3, 2026. Market research included searching government databases (SAM.gov, CPARS, and the EDA Commercial Item Database), analyzing commercial catalog pricing, and evaluating responses to RFI W911SR-26-X-0008.

Summary of RFI W911SR-26-X-0008 Vendor Responses & SME Technical Evaluation:

Aptagen Labs, LLC (CAGE: 436H7, UEI: HEK9BF17MKL3, Jacobus, PA):

10. Interested Sources To date, no other capable sources have expressed a written interest in this requirement. All four RFI respondents were evaluated, and only Aptagen Labs, LLC demonstrated the required technical capability.

11. Other Facts Procurement history:

Prior custom aptamer purchases were executed via open-market commercial delivery orders under simplified acquisition procedures.

Sequence Ownership: Aptamer sequences can be from the public domain or designed and owned by the Department of War; the contractor performs custom synthesis to order.

Market Dynamics: The commercial market for custom aptamer synthesis remains highly specialized and contracted, with several general suppliers exiting catalog aptamer synthesis to focus solely on early-stage discovery services.

Other facts:

None / Not applicable.