JOFOC_Redacted_SAM_1.pdf

United States Department of the Interior

INTERIOR BUSINESS CENTER

Washington, DC 20240

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION (JOFOC)

FOR COMMERCIAL PRODUCTS/SERVICES OVER THE SIMPLIFIED

ACQUISITION THRESHOLD (SAT) USING SIMPLIFIED PROCEDURES

AUTHORITY: Revolutionary FAR Overhaul (RFO) 12.102(b) and 41 U.S.C. 1901

SOL No. 140D0426Q0839

1. Identification of the agency and the contracting activity, and specific identification of the document as a “Justification for Other than Full and Open Competition.”

This document is a Justification for Other than Full and Open Competition for the Department of the Interior (DOI), Interior Business Center (IBC), Acquisition Services Directorate (AQD), on behalf of the National Institutes of Health (NIH)/National Institute of Allergy and Infectious Diseases (NIAID).

2. Nature and/or description of the action being approved.

This is a new requirement for one BioAssemblyBot (BAB) 400 (BAB400), which will be purchased directly from Advanced Solutions Life Sciences, LLC (Advanced Solutions).

3. A description of supplies or services required to meet the agency’s needs (including the estimated value).

The BAB400 is a robotic cell-culture and bioprinting platform built around a six-axis robotic arm that swaps between interchangeable tool "hands" to carry out different laboratory tasks on the same set of plates, without a person physically handling them.

The platform includes the BioApps Studio software environment, providing browser-based development and execution of autonomous laboratory workflows. The software integrates robotic execution, instrument control, workflow traceability, experiment recovery, and artificial intelligence (AI)-enabled process management into a unified platform capable of supporting continuously learning laboratory operations.

The government estimate for this acquisition The award will be firm-fixed-price. The period of performance is approximately 15.5 months and will include a three-year warranty on parts and a one-year software maintenance agreement that is effective upon installation. The three-year warranty on the parts includes associated travel, labor and testing during a breakage or interruption in service.

4. An identification of the statutory authority permitting other than full and open competition.

This is an acquisition conducted under the authority of the Simplified Procedures for Acquisition of Commercial Products and Commercial Services. The statutory authority permitting restricting competition is 41 U.S.C 1901 as implemented by RFO 12.102(b).

5. A demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

The Government requires an integrated autonomous laboratory platform capable of supporting the NIH/NIAID Bio Genesis Pilot Autonomous Human Biology Laboratory.

The Advanced Solutions BAB400 possesses a unique combination of hardware, software, robotics, and workflow orchestration capabilities that are not available in a single commercially available platform from other manufacturers.

Unlike conventional laboratory automation systems that require multiple independent instruments and third-party software integration, the BAB400 provides a fully integrated platform combining robotic manipulation, precision liquid handling, automated incubation, high-content brightfield and fluorescence imaging, precision single-cell and organoid dispensing, environmental control, and AI-ready workflow orchestration within a single coordinated system. This integrated architecture is essential for developing closed-loop, AI-directed experimental workflows where experimental design, robotic execution, imaging, quality assessment, and iterative optimization occur seamlessly without manual intervention.

A unique capability of the BAB400 is its precision organoid handling technology, which utilizes impedance-based detection and piezoelectric dispensing to isolate and manipulate individual cells and organoids while minimizing shear stress and preserving viability. This capability is critical for standardized organoid production and quality-controlled human biological systems required for the NIH Standardized Organoid Modeling (SOM) Initiative. Comparable laboratory automation platforms are designed primarily for traditional liquid handling or high-throughput screening and do not provide integrated, low-shear manipulation of complex three-dimensional organoid cultures within the same autonomous platform.

In addition, the BAB400 includes the proprietary BioApps Studio software environment, which provides browser-based workflow development, integrated robotic orchestration, experiment traceability, workflow recovery, and AI-ready laboratory execution. These capabilities are essential to the Government's objective of developing autonomous laboratory workflows under the NIH Bio Genesis initiative. Equivalent commercial systems generally require integration of multiple vendor-specific software packages and custom engineering, substantially increasing implementation complexity, development time, validation requirements, and long-term operational risk.

The Government intends to use the BAB400 as the foundational platform for developing autonomous laboratory capabilities that integrate robotics, AI-enabled experimentation, standardized human organoid systems, multimodal characterization, and digital laboratory infrastructure. The platform will initially support the HDC-OID and CUBE- OMICS programs while serving as the technology development environment for future deployment within the NIH SOM Center. Because these activities require seamless integration between robotics, imaging, environmental control, workflow management, and AI-enabled decision support, substitution with multiple independent commercial systems would significantly compromise system interoperability, increase engineering complexity, reduce reproducibility, and delay implementation of critical NIH strategic initiatives.

Failure to procure the BAB400 would require the Government to assemble a custom automation platform from multiple vendors, necessitating substantial software development, custom hardware integration, validation, and ongoing maintenance. This would increase overall project cost, delay deployment of the Pilot Autonomous Human Biology Laboratory, postpone planned collaborations supporting the NIH Bio Genesis initiative, and delay implementation of AI-enabled autonomous laboratory capabilities supporting the NIH SOM Initiative. These delays would adversely impact the Government's ability to establish standardized, reproducible, and scalable autonomous laboratory infrastructure aligned with NIH strategic priorities and interagency collaboration with the Department of Energy's Genesis Mission Platform.

Accordingly, the Advanced Solutions BAB400 represents the only commercially available solution that provides the required integrated combination of robotic automation, precision organoid handling, multimodal imaging, AI-ready workflow orchestration, and scalable autonomous laboratory functionality necessary to satisfy the Government's minimum technical and programmatic requirements.

6. A description of the efforts made to ensure that offers are solicited from as many potential sources as practicable, including whether a notice was or will be publicized as required by RFO part 5 and, if not, which exception under Part 5 applies.

On 07/22/26, the contracting officer posted a pre-solicitation/notice of intent to sole source on SAM.gov, allowing offerors to provide alternative instruments in a 2-page response no later than 10 AM ET, 08/05/26. No alternatives were submitted.

7. A determination by the contracting officer that the anticipated cost to the

Government will be fair and reasonable.

The contracting officer will determine that the price is fair and reasonable by conducting price analysis in accordance with RFO 12. Since this acquisition is over the simplified acquisition threshold, the contracting officer will ensure to evaluate pricing in accordance with DOI Acquisition, Arts, and Asset Policy (AAAP) 0024 “Enhancing Competition,” including utilizing any available previous award prices for comparative price analysis.

8. A description of the market research conducted (see part 10), and the results or a statement of the reason market research was not conducted.

Comprehensive market research was conducted by the program office to identify commercially available laboratory automation platforms capable of supporting the program office's requirements for the NIH/NIAID Bio Genesis Pilot Autonomous Human Biology Laboratory. The evaluation included commercially available laboratory automation systems from major suppliers of liquid handling robotics, laboratory automation, imaging platforms, and autonomous laboratory technologies through vendor discussions, product demonstrations, technical literature, manufacturer specifications, and review of commercially available solutions.

The program office evaluated whether commercially available platforms could provide the integrated capabilities required to support AI-enabled autonomous laboratory workflows, including standardized human organoid production, precision handling of complex three-dimensional biological systems, automated incubation, multimodal imaging, robotic workflow execution, and AI-ready workflow orchestration. The market assessment included both integrated laboratory automation platforms and modular solutions that would require combining equipment from multiple vendors.

The market research determined that while several vendors offer high-quality liquid handling systems, automated imaging instruments, incubators, or robotic platforms individually, these systems are generally optimized for traditional laboratory automation or high-throughput screening and require significant custom integration, third-party software development, and engineering support to achieve the program office's desired autonomous laboratory capability. None of the evaluated alternatives demonstrated an integrated commercial solution capable of combining precision organoid handling, robotic manipulation, environmental control, multimodal imaging, AI-ready workflow management, and modular expansion within a single coordinated platform.

The Advanced Solutions BioAssemblyBot 400 was identified as the only commercially available system that integrates these capabilities into a unified autonomous laboratory platform specifically suited for developing standardized human organoid workflows and AI-enabled experimental execution. The system's modular architecture, integrated BioApps Studio software environment, precision single-cell and organoid dispensing, robotic orchestration, and seamless integration of incubation, liquid handling, and imaging capabilities uniquely support the Government's requirements for establishing a Pilot Autonomous Human Biology Laboratory.

The program office also considered constructing a custom laboratory automation platform using equipment from multiple manufacturers. However, this approach would require extensive custom software integration, hardware engineering, workflow validation, vendor coordination, and long-term maintenance across multiple proprietary systems. Such an approach would substantially increase implementation complexity, cost, technical risk, and deployment time while introducing interoperability challenges that could compromise reproducibility and future scalability.

Based on the market research conducted, the program office concluded that the Advanced Solutions BioAssemblyBot 400 represents the only commercially available integrated platform capable of meeting the technical, operational, and programmatic requirements of the NIH/NIAID Bio Genesis Pilot Autonomous Human Biology Laboratory within the required project schedule.

The program office’s requirement is not for a standalone laboratory instrument, but for an integrated autonomous laboratory platform that will serve as foundational infrastructure supporting NIH strategic initiatives in AI-enabled biomedical research, standardized human organoid systems, and autonomous laboratory development.

Market research demonstrated that while individual components exist from multiple commercial vendors, no other commercially available solution provides the integrated combination of robotics, precision organoid manipulation, imaging, environmental control, workflow orchestration, and AI-ready software required to achieve these objectives without significant custom integration and associated technical risk.

The contracting office also executed an online search for the BAB400. Multiple sites were found containing information about the BAB400’s functionality. However, there were no sites outside of Molecular Devices’ and Advanced Solutions’ that allowed for requesting a quote. Molecular Devices and Advanced Solutions were previously in a partnership and as of 05/26, Advanced Solutions has become solely responsible for the sale of the BAB400. The contracting office also reviewed the SAM.gov website for previous BAB400 purchases. The only result for “BAB 400” was the pre-solicitation/notice of intent to sole source for this procurement that the CO had posted on 07/22/26. A search for “BioAssemblyBot 400” resulted in one award issued to Advance Solutions by the Veterans Affairs (36C24725P0728) on 07/14/25 totaling $142,732 and one award issued by the Environmental Protection Agency (68HE0B24P0698) to Advanced Solutions on 03/10/25 totaling $157,026. The market research conducted by the contracting officer indicated that the BAB400 is only available through direct sales to Advanced Solutions.

9. Any other facts supporting the use of other than full and open competition;

such as:

See section 5.

10. A listing of the sources, if any, that expressed an interest in the acquisition in writing.

Not applicable. There were no responses to the pre-solicitation/notice of intent to sole source

11. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

The proposed acquisition is limited to the current requirement because market research determined that only the Advanced Solutions BioAssemblyBot 400 presently provides the integrated autonomous laboratory capabilities required to support the NIH/NIAID Bio Genesis Pilot Autonomous Human Biology Laboratory.

Prior to any future acquisitions, the program office will conduct updated market research to evaluate advances in commercially available laboratory automation platforms, robotics, AI-enabled workflow management, and autonomous laboratory technologies. As the commercial marketplace continues to evolve rapidly, additional vendors may develop comparable integrated capabilities that could satisfy future Government requirements.

To maximize future competition, the Government will:

Conduct new market research before future acquisitions to identify emerging commercial technologies and qualified vendors.

Develop performance-based technical requirements focused on functional outcomes rather than proprietary product features whenever feasible.

Utilize open and interoperable data standards, standardized file formats, and non-proprietary interfaces to facilitate integration with future laboratory automation platforms and software.

Minimize vendor lock-in by designing laboratory workflows, data management practices, and AI infrastructure to remain portable across compatible commercial systems where practical.

Periodically evaluate alternative commercial solutions as autonomous laboratory technologies mature and the marketplace expands.

The current acquisition represents the initial deployment of a pilot autonomous human biology platform. Experience gained during implementation will be used to refine future technical requirements, promote broader commercial competition where practical, and ensure subsequent acquisitions are based on evolving mission needs.

12. Contracting officer certification that the justification is accurate and complete to the best of the contracting officer’s knowledge and belief.

I certify that this justification is accurate and complete to the best of my knowledge and belief.