N_POSTING_Addendum to Class J and A_Beacon Platform_FINAL_Redacted.pdf

Optofluidic Platform

AMBIS 2018841

Addendum to Class Justification for Other Than Full and Open Competition

COVID-19 Response

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. DHHS/National Institutes of Health [NIH]/National Institute of Allergy & Infectious Diseases[NIAID]/Acquisitions Management Operations Branch

[AMOB]

b. Sponsoring organization. National Institute of Allergy and Infectious Diseases [NIAID], Division of Intramural Research [DIR], Laboratory of Immunogenetics (LIG)

c. Project Officer information.

• Project Officer name.

• Mailing address.

• E-mail address.

• Telephone number.

2. Acquisition purpose and objectives. There is an urgent need to develop new tools against the COVID-19 virus using the best available technology. To this end, the National Institute of Allergy and Infectious Diseases (NIAID) Laboratory of Immunogenetics (LIG) requires an emergency purchase of a Berkeley Lights Beacon Optofluidic platform to rapidly isolated human monoclonal antibodies against SARS-CoV-2 (COVID-19).

3. Project background. NIAID intramural and extramural scientists are working towards rapidly improving our understanding COVID-19. NIAID’s LIG research focuses on the cellular and molecular mechanisms underlying the signaling functions of immune cell receptors. This research encompasses a wide spectrum of experimental approaches, from the structural determination of immune receptors to the live cell image analysis of the behavior of chemotactic receptors. LIG researchers are working to find antibodies for COVID-19. The Beacon platform would significantly reduce the antibody screening time and allow LIG researchers to rapidly obtain new antibodies against the coronavirus. The Beacon is a cutting-edge instrument that is being used by major pharmaceutical and biotechnology companies to isolate human monoclonal antibodies against various targets. This acquisition directly addresses the mission and latest global health threat by providing state of the art instrumentation for LIG research to help respond quickly to COVID-19. This is a commercial supplies requirement. There are no known prior NIAID, NIH Institutes, or other federal agency purchases for this state-of-the-art system. These products/services are needed for critical research to assist in finding antibodies to fight COVID-19. The COVID-19 national public health emergency will not permit a delay resulting from a competitive solicitation. Research on finding antibodies for COVID-19 is like finding a “needle in the haystack”.

Without the ability to quickly guide and isolated thousands of cells, the discovery of antibodies to fight COVID-19 could take much longer and potentially jeopardize mission-related research and the lives of individuals across the globe. It is imperative that NIAID obtain an instrument that allows quick screening of cell for potential life-saving antibodies. Due to the urgent and critical need to respond to the COVID- 19 public health emergency, NIAID requires acquisition of this system now and delay in award would result in serious impact to LIG’s COVID-19 research.

4. Project title. Optofluidic Platform for Antibody Discovery

5. Project description. This requirement is for commercially available Berkeley Lights Beacon Optofluidic Platform and associated installation and support services as provided in Attachment A below. The Beacon optofluidic platform for antibody discovery provides accelerated single-cell screening and high-resolution analysis to identify and isolate antigen-specific antibody-secreting cells in a single day. This groundbreaking technology is powered by Berkeley Lights OptoSelect technology which enables the precise movement, positioning, and interaction of cells on an opto-fluidic chip. Its integrated and automated workflows – import, culture, assay, and export, can significantly accelerate antibody discoveries. Beacon platform is a research-only system for antibody discovery and not to be used in diagnostic procedures. This system is 46” wide, 34” deep, and 71.5” high. The system will include the latest upgrade, Opto Plasma B Discovery 2.0 Upgrade package, which provides higher throughput and higher content. Proprietary software is included with the system and will require ongoing maintenance to ensure the system has the latest updates and patches. The system includes a one-year warranty which includes software updates/patches. Once the system is delivered, Berkeley Lights will provide onsite installation, testing, and make sure the instrument is properly calibrated. The requirement also includes 15 days of onsite application support which must be utilized within the first six months of award. Berkeley Lights will provide a subject matter expert to assist LIG researchers with developing specific workflows for the COVID-19 research. These products/services are of a type customarily used for nongovernmental purpose and that have been sold or leased to the general public.

As such, commercial products/services under FAR Part 12 are appropriate for this requirement.

6. Proposed contract/order type: Firm fixed price

7. Acquisition identification number: AMBIS 2018841

8. Total estimated dollar value:

9. Total Period of Performance: estimated March 25, 2020 – September 24, 2020

10. Name and address of the proposed contractor(s) Berkeley Lights 5858 Horton Street Suite 320 Emeryville, CA 94608

11. Nature of the acquisition and proposed unique qualifications of the contractor(s).

No other products, except the Beacon platform, can reduce antibody screening time per donor from three weeks to 1-2 days and would enable NIAID researchers to obtain antibody heavy and light chain sequences within 3-4 days after initial handling of peripheral blood mononuclear cell (PBMC) samples, thus allowing them to rapidly obtain new human monoclonal antibodies against the coronavirus. The system must also be able to work at a single cell level which enables discovery of greater diversity of potential protective antibodies for COVID-19. Additionally, NIAID requires a system with a footprint which would fit within the existing lab space. The Beacon platform is a refrigerator-sized device which would easily fit into the available space. Specific capabilities of the Beacon platform include:

• Unique, proprietary technology called OptoElectroPositioning, or OEP, creates a small repulsive force on any micro-object, for example – cells, beads, yeast or any other small objects generally from 2 to 20um in diameter. These cells or other micro-objects are imported into the microfluidic chip suspended in any media.

• Ability to place a single cell in a 2-4 nanoliter volume, allowing for unprecedented precise experimentation and further interrogation on the single-cell level by a variety of different assays including binding assays, fluorescence assays, morphological and phenotypic assays and a number of functional assays.

• After loading single plasma B-cells in proprietary NanoPens (~0.4nL), across 4 chips in parallel each containing >11,000 NanoPens, multiple assays can be performed to determine which B-cell cells are secreting the antibody of interest.

• Assays are performed on chip, in real-time, and can include antigen-binding assays using either antigen linked to beads or natively membrane-bound on cells to find potently neutralizing antibodies against diseases such as coronavirus COVID-19 and Malaria.

• The Opto Plasma B Discovery 2.0 workflow provides access to greater B cell diversity by enabling multiple workflows from a single plasma B cell sample coupled with high-efficiency, simplified recovery of antibody heavy/light chain (Hc/Lc) sequences using OptoSeq BCR.

• Tens of thousands of individual plasma B cells are manipulated by light and cloned into nanoliter-sized NanoPen™ chambers on a microfluidic chip using Berkeley Lights OptoSelect™ technology in an automated fashion.

• The small volume of these chambers enables rapid, precise and highly sensitive assays that can be completed in less than 1 hour because secreted antibody levels reach detectable levels within minutes.

• Following functional characterization and automated assay scoring, OptoSeq BCR enables on-chip genomics integration to enable simple and efficient recovery of paired heavy/light chain sequences. Plasma B cells are lysed in their respective NanoPen chambers and mRNA is captured on beads for on-chip cDNA synthesis. Sequences associated with desired function can then be recovered for several days without sequence degradation due to death of fragile plasma B cells.

• The Beacon platform can process and find rare cell phenotypes using limited and precious samples (1,000-cell and 10,000-cell samples) that would not be possible on a flow cytometer.

• For TCR discovery workflows, the platform can be programed to load a single T cell, a few IFNγ beads and tumor cells, and then export only those T-cells that show IFNγ secretion and tumor cell killing phenotypes.

• The Beacon has a unique ability to recover live cells of interest after culturing and assaying. Individual cells or colonies of interest selected and exported for on-target sequencing or expansion of the validated clones.

12. Contractor responsibility. A contractor responsibility determination is provided in the contract file.

13. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies. Due to the unusual and compelling urgency to award this order immediately to support COVID-19 antibody research, soliciting from other sources would result in an unacceptable delay. A notice is not required in this situation in accordance with the FAR 5.202(a)(2) exception.

14. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable. The techniques identified at FAR 13.106-3(a)(2) will be used to ensure award will be made at fair and reasonable prices. NIAID will consider the independent Government estimate, market research, and comparison with similar items in the marketplace. A final determination by the Contracting Officer will be conducted prior to award of this contract and documented in the file.

15. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Market research was conducted in accordance with FAR Part 10. The Program Office conducted the initial market research by reviewing NIAID’s existing equipment and scanning the market for technology that could satisfy the Government’s requirement for fast, high quality antibody scanning. Their research concluded that Berkeley Lights is the only source of technology that can meet NIAID’s requirements.

Berkeley Lights is the sole manufacturer and distributor of the Beacon Platform in the United States.

Market research conducted by the Contract Specialist (CS) included a review of mandatory priorities in accordance with FAR Subpart 8.002(a)(1) Priorities for Use of Government Supply Sources and she determined that none of the mandatory Government sources could satisfy this requirement. Additional market research by the CS included contacting knowledgeable Government and Industry professionals and researching previous purchases for similar requirements. The CS contacted Berkeley Lights and learned that they do not have authorized resellers and their products are only available directly from the manufacturer through the open market. Berkeley Lights products are no available through existing government-wide contract vehicles such as GSA Federal Supply Schedules. Due to the urgent need to obtain this instrument immediately, additional market research such as a Sources Sought notice was not conducted. In conclusion, based on the market research conducted it supports a sole source, open market award to Berkeley Lights as the only known source available to the Government for this requirement.

APPENDIX A – BILL OF MATERIALS

CLIN Mfg. Part # Manufacturer Description Unit # of

Units

1 100-00026 Berkeley Lights Beacon Negative Pressure System each 1

2 870-08027 Berkeley Lights Opto Plasma B Discovery 2.0 Upgrade Package each 1

3 750-08022 Berkeley Lights Beacon Installation and Qualification each 1

4 870-00013 Berkeley Lights On Site Application Support, 5 days each 3

5 870-08016 Berkeley Lights Freight Fee for Beacon Platform each 1

Contracting Officer Date

Senior Contracting Officer Date