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JUSTIFICATION REVIEW DOCUMENT FOR COMMERCIAL ITEMS FAR PART 13 SIMPLIFIED ACQUISITION JUSTIFICATION AND APPROVAL FOR OTHER THAN FULL AND OPEN COMPETITION Programs/Equipment: The Synthetic Biology Bran... JUSTIFICATION REVIEW DOCUMENT FOR COMMERCIAL ITEMS FAR PART 13 SIMPLIFIED ACQUISITION JUSTIFICATION AND APPROVAL FOR OTHER THAN FULL AND OPEN COMPETITION Programs/Equipment: The Synthetic Biology Branch requires a system for Synthetic Genetic Array Instruments. Authority: 41 U.S.C. 1901(e)(2), implemented by FAR 13.501(a) -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. Amount: $[REDACTED] Prepared by: [REDACTED DSN: [REDACTED] Research Chemist Date: 27 June 2024 Email: [REDACTED] Contracting Officer: Lee E. Troope, Jr. DSN: 301.290.1090 Contracting Officer Date: 27 June 2024 Email: lee.e.troope.civ@army.mil Technical: [REDACTED] DSN: [REDACTED] Research Chemist Date: 27 June 2024 Email: [REDACTED] Requirements: [REDACTED] DSN: [REDACTED] Branch Chief Date: 27 June 2024 Email: [REDACTED] FAR PART 13 SIMPLIFIED ACQUISITION JUSTIFICATION AND APPROVAL FOR OTHER THAN FULL AND OPEN COMPETITION 1. Contracting Activity: U.S. Army Contracting Command – Aberdeen Proving Ground (ACC_APG), Adelphi Contracting Division, (CCAP-MDI), 2800 Powder Mill RD, Adelphi, MD 20783. 2. Description of Action: The Synthetic Branch of the Army Research Directorate, in support of the Office of the Under Secretary of Defense (OUSD) Tri-Service Biotechnology for Resilient Supply Chain program (TBRSC) requests a firm-fixed price (FFP) contract (W911QX-24-P-0166) with Singer Instrument Company Limited, Roadwater, Wathchet, Somerset, TA23 0RE, United Kingdom. The Government projects award for August 2024 and fiscal year 2023, funds type Research, Development, Test and Evaluation) funds will be used. X An acquisition plan is not required because this procurement either does not meet the threshold at Defense Federal Acquisition Regulation Supplement 207.103(d)(i) or is an R&D acquisition and does not meet the definition of services in 10 U.S.C. 2330(c)(2). 3. Description of Supplies/Services: One (1) PIXL instrument, one (1) ROTOR+ instrument, and one (1) Phenobooth+ instrument for implementation of the Synthetic Genetic Array system (including associated software packages, accessories, system installation, training & acceptance at customer's site, and an associated warranty) and one (1) additional year of support (including repair, maintenance, labor, and remote technical support). PIXL: Part # Description Qty. Unit Price Total PIX-001 PIXL 1 $[REDACTED] $[REDACTED] PUL-001 Pickup line 1 $[REDACTED] $[REDACTED] BAK-001 Blade and Anvil Kit 1 $[REDACTED] $[REDACTED] KIN-001 Kinematic Module 1 $REDACTED] $[REDACTED] PDD-001 Dump Drawer 1 $[REDACTED] $[REDACTED] BCS-001 Barcode Scanner 1 $[REDACTED] $[REDACTED] PET-002 Petri Dish Adapter (90mm) 1 $[REDACTED] $[REDACTED] PXF-001 452nm filter 1 $[REDACTED] $[REDACTED] PXF-002 510nm filter 1 $[REDACTED] $[REDACTED] PXF-003 527nm filter 1 $[REDACTED] $REDACTED] PXF-004 615nm filter 1 $[REDACTED] $[REDACTED] IPX-004 Installation, training 1 $[REDACTED] $[REDACTED] SLS-002 1 yr. Support 1 $[REDACTED] $[REDACTED] SHI-002 Shipping 1 $[REDACTED] $[REDACTED] PIXL Total: $[REDACTED] ROTOR+: Part # Description Qty. Unit Price Total RT2-001 ROTOR + 1 $[REDACTED] $[REDACTED] CMP-USA-002 Compressor 1 $[REDACTED] $[REDACTED] DDR-002 Dump Drawer 1 $[REDACTED] $[REDACTED] HOP-002 Pad Hopper 1 $[REDACTED] $[REDACTED] BCS-001 Barcode Scanner 1 $[REDACTED] $[REDACTED] PLU-003 PlusPlates 1 $[REDACTED] $[REDACTED] VSP-001 Vari Start Pack 1 $[REDACTED] $[REDACTED] RIC-004 Installation, training 1 $[REDACTED] $[REDACTED] SLS-002 1 yr. Support 1 $[REDACTED] $[REDACTED] SHI-002 Shipping 1 $[REDACTED] $[REDACTED] ROTOR+ Total: $[REDACTED] PHENOBOOTH+: Part # Description Qty. Unit Price Total PHB-007 PhenoBooth+ 5 Channel 1 $[REDACTED] $[REDACTED] PET-001 Petri Dish Adapter 1 $[REDACTED] $[REDACTED] PBF-001 510nm filter 1 $[REDACTED] $[REDACTED] PBF-002 527nm filter 1 $[REDACTED] $[REDACTED] PBF-003 615nm filter 1 $[REDACTED] $[REDACTED] SLS-002 1 yr. Support 1 $[REDACTED] $[REDACTED] SHI-002 Shipping 1 $[REDACTED] $[REDACTED] Phenobooth+ Total: $[REDACTED] Completion Date: 16 weeks after receipt of order Total Value: $[REDACTED] 4. Authority Cited: 41 U.S.C. 1901(e)(2), implemented by FAR 13.501(a) -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. 5. Reason for Authority Cited: As described at FAR 6.302-1(a)(2), when the supplies or services required by the agency are available only from one responsible source, or for DoD, NASA and the Coast Guard, from only one or a limited number of responsible sources, and no other types of supplies or services will satisfy agency requirements, full and open competition need not be provided for. As further described in FAR 6.302-1(c), an acquisition or portion of an acquisition that uses a brand-name description or other purchase description to specify a particular brand-name, product, or feature of a product, peculiar to one manufacturer does not provide for full and open competition, regardless of the number of sources solicited; and shall be justified and approved in accordance with FAR 6.303 and 6.304. The Army Research Laboratory (ARL) requires the ‘Synthetic Genetic Array’ instruments made by Singer Instrument Company Limited to study and screen the function of micro-organisms critical to biotechnology development, biomanufacturing, and to study how organisms in the field are impacting Army materiel and other assets. This collection of interoperable instruments forms a genetic screening platform to manipulate and evaluate microbial genetic variants. The end goal is to streamline the Army biotechnology product development pipeline in that strains can be rapidly screened, characterized and optimized. The applications of these strains include Army applications such as energetics, mineral reclamation, and biosensors. Genetic screening is a necessary function of many biological laboratories. Currently, ARL does not have the ability to rearray and evaluate microbial colonies with the throughput needed to screen thousands of genetic variants at a time. Being able to screen microbial variants for novel properties is central to engineering microbial strains for biomanufacturing of materials and small molecules for Army applications. The ability to rapiding prototype the genetic engineering of microbial strains for the production of novel molecules and materials for the DoD is at the core of the TBRSC program. If ARL is unable to achieve rapid high-throughput screening of microbial variants, ARL would be forced to use lower throughput more laborious processes, and cause delay or impair our ability to rapid prototyping of new strains and add to the time and materials cost of doing similar work without these instruments. Ultimately, the latter would result in being unsuccessful in meeting TBRSC program goals. Broadening the capabilities at ARL will compliment and support the capabilities of the tri-service Rapid Biological Prototyping Consortium of which ARL is a key member. Singer Instruments' Synthetic Genetic Array (SGA) systems are unique for several reasons: 1. High Throughput Screening: Singer Instruments' SGA systems are designed for high-throughput genetic interaction screening, allowing researchers to analyze thousands of genetic interactions simultaneously. This capability is crucial for large-scale studies in functional genomics and systems biology. 2. Automation and Precision: These systems are highly automated, reducing manual labor and the potential for human error. The precision of the robotic handling ensures accurate and reproducible results, which is essential for high-confidence data in genetic studies. 3. Flexibility and Customization: Singer Instruments' SGA systems offer flexibility in experimental design, accommodating various types of genetic libraries and different microorganisms. This adaptability makes them suitable for a wide range of applications in biotechnology, biomanufacturing, and microbiological research. 4. Integration with Other Technologies: The SGA systems can be integrated with other laboratory technologies and workflows, such as colony pickers, liquid handlers, and imaging systems. This integration enhances the overall efficiency and effectiveness of the experimental process. 5. User-Friendly Software: The systems come with intuitive software that simplifies the setup, execution, and analysis of experiments. The software is designed to handle complex genetic datasets, making it easier for researchers to interpret results and draw meaningful conclusions. 6. Proven Track Record: Singer Instruments has a long history and solid reputation in the field of laboratory automation and genetic research tools. Their SGA systems have been used in numerous high-profile studies, demonstrating their reliability and effectiveness in advancing genetic research. 7. Support and Service: Singer Instruments provides comprehensive support and service to their customers, ensuring that the systems are properly maintained, and any issues are promptly addressed. This support is crucial for maintaining the high performance of the equipment over time. These features collectively make Singer Instruments' Synthetic Genetic Array systems stand out in the market, providing researchers with powerful tools to advance their studies in genetics, biotechnology, and microbiology. Singer Instruments Company Limited holds patents for various aspects of their SGA systems and there are no third-party distributors of the technology. These systems are renowned for their high-throughput and automated capabilities, which are crucial for large-scale genetic screenings. One of the unique features of Singer Instruments’ SGA systems is their integration with the ROTOR+ platform, a compact and efficient bench-top robot designed for the rapid manipulation and screening of microbial colonies at high densities. The ROTOR+ system is highly valued for its speed and precision, capable of replicating entire yeast deletion libraries in quadruplicate in less than 20 seconds. This makes it particularly effective for functional and chemical genomic studies, offering unmatched throughput and efficiency compared to other systems. Furthermore, Singer Instruments’ systems support a range of genetic interaction studies, including synthetic lethal and synthetic sick interactions, which are pivotal in understanding gene functions and pathways. The systems can also be used for suppressor mapping, identifying genetic suppressors that can alleviate the growth defects caused by specific mutations, thereby revealing genes that function in the same pathway. The Singer Instruments SGA Instrument trio—comprising the PIXL, ROTOR+, and PhenoBooth instruments—is uniquely suited to meet the Government’s technical requirements for several reasons: 1. Integration and Interoperability: These instruments are designed to work seamlessly together, providing a comprehensive solution for high-throughput genetic screening. The integration allows for streamlined workflows from colony manipulation to imaging and hit-picking. 2. High Density Colony Arrays: The PIXL and ROTOR+ instruments facilitate the manipulation and screening of high-density microbial colony arrays. This capability is essential for large-scale genetic studies where the density of colonies can significantly impact the throughput and efficiency of the screening process. 3. Imaging and Hit-Picking: The PhenoBooth instrument supports high-resolution imaging and accurate hit-picking of strain variants. This is critical for strain engineering pipelines where precise identification and selection of variants are necessary for downstream applications. 4. Flexibility in Assay Design: The instruments allow for flexibility in the types of microbial plates used, enabling researchers to conduct high-density clonal screens on various plate formats. They also support the transfer of colonies to and from liquid cultures using a wide range of optical parameters, providing researchers with the ability to design and implement diverse assays. 5. Optical Parameters: The use of a wide array of optical parameters enhances the versatility of the system, allowing for detailed analysis and characterization of microbial colonies based on different visual and spectral criteria. These features collectively offer Army researchers the greatest flexibility and efficiency in their genetic screening and strain engineering efforts, making the Singer Instruments trio an unparalleled choice for these applications. 6. Efforts to Obtain Competition: The Contracting Officer shall publish the notices required by FAR 5.201 and any bids or proposals received shall be considered. A synopsis was posted to betaSAM.gov on 27 June 2024 with a response date of 09 July 2024 by 12:00PM Eastern Standard Time. There was one (1) response to the synopsis posted on betaSAM.gov from Sky Qatar Company but was found by the Technical Point of Contact, [REDACTED] to be inadequate and missing requirements. Because this is a sole source action, effective competition is not applicable. Subcontracting competition is not possible due to the work involving proprietary technology. The prime contractor needs to perform these tasks in-house to maintain control over the patented technology. 7. Actions to Increase Competition: ARL attempted to identify multiple sources for the technology being procured by researching products from Molecular Devices and their QPix line of colony pickers and instruments. ARL currently owns and uses a Molecular Devices QPix 420 colony pickers. However, for this particular application, a platform capable of picking colonies from more than just E. coli and yeast was desired, with greater optical and format flexibility than our current system allows. Additionally, picking without the need for an alcohol sterilization step is highly desirable due to the potential sensitivity of some organisms to this process. These factors limit the applicability of Molecular Devices' current instrument offerings. In our research, only Singer Instrument Company Limited offers the ability to create high-density arrays with the capability to spot over 6,000 colonies in an SBS-style plate. This level of throughput meets the Government’s needs for this system and, when combined with the other instruments offered by Singer, forms a complete pipeline for screening and manipulation of microbial genetic variants consistent with the intended application and existing workflows at ARL. It is important that the instruments ‘work together’ to feed data and information from one instrument to another to create the workflows that the Government requires. Again, only Singer Instrument Company Limited offers a combination of instruments that meet these needs. The Government will monitor the commercial marketplace for similar systems that meet the minimum technical requirements. ARL will continue to pursue web-based research, consultations, and attend trade shows or webinars to help locate alternative manufacturers that can provide the required screening needs. In the future, if another manufacturer is found to provide a reliable alternative, ARL will not hesitate to purchase the product competitively. 8. Market Research: Market research was conducted from November through December 2023 by a Research Chemist within the Biotechnology and Biological Sciences Division, Synthetic Biology Branch. The Research Chemist searched the General Supply Schedule (GSA) website, contacted subject matter experts within the Government and academic experts in the field, queried Government-wide databases of contracts and other procurement instruments intended for use by multiple agencies and other Government and commercial databases that provide information relevant to agency acquisitions, and reviewed various internet resources to meet the Government’s requirements. Market research found that Singer Instrument Company Limited is the only company capable of meeting the Government’s minimum requirements for one (1) high-throughput SGA system capable of meeting the specified needs. The inability to meet the sequencing demands at ARL in a timely manner will delay the rapid prototyping of strains developed for biomanufacturing for the DoD, potentially resulting in failure to meet the TBRSC program goals. Market research identified one (1) company, Molecular Devices, which offered colony picking options similar to the Singer Instruments PIXL. However, the features (or lack thereof) did not meet the needs of the current genetic pipeline. No manufacturer was found to offer a colony pin arrayer similar to the Singer Instruments ROTOR+ instrument, nor a colony imaging system comparable to the Phenobooth+. Therefore, Singer Instrument Company Limited was the only source found capable of meeting all the Government’s minimum technical requirements. 9. Interested Sources: See Paragraph 6 for the synopsis information. To date, one (1) other source has written to express interest in the acquisition but was found technically unacceptable. 10. Other Facts: Not Applicable 11. Technical Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief. Signer’s Title: Research Chemist 12. Requirements Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief. Signer’s Title: Branch Chief 13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable. This determination will be made using the following: __ Cost analysis X Price analysis __ Should-cost X IGE __ Audit: __ Other: As a part of this basis, certified cost or pricing data: __ will be required. X will not be required and the following exception applies (FAR 15.403): __ Prices that will be agreed upon are based on adequate price competition. __ Prices that will be agreed upon are based on prices set by law or regulation. X A commercial item is being acquired. __ A waiver has been granted by the head of the contracting activity (HCA) in accordance with DFARS PGI 215.403-1. __ The contract action is a modification to a contract or subcontract for commercial item(s). __ The estimated cost of the contract action is less than the threshold for certified cost or pricing data. 14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief. ?