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This notice is issued to help determine the availability and type of qualified Small Business companies technically capable of meeting this potential government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. The notice is strictly for research and information purposes only.
The information requested will assist the Government in determining the appropriate acquisition method including small business socio-economic set-aside possibilities and to determine the availability of qualified Small Business companies technically capable of meeting the Government's potential requirement. All Small Business companies with the capability and availability to perform the requirement under the applicable NAICS code are invited to submit a response to this notice.
NORTH AMERICAN CLASSIFICATION SYSTEM (NAICS) CODE
The NAICS code applicable to this requirement is 541380-Testing Laboratories with associated small business size standard of 15 Million USD.
BACKGROUND
The National Institutes of Health (NIH) is the nation's leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. The National Center for Advancing Translational Sciences (NCATS) is a translational science center whose mission is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. The Division of Pre-Clinical Innovation (DPI) at NCATS plans, conducts and uses both internal and contract resources to advance collaborative research projects across the pre-clinical phases of the translational science spectrum. To establish and move stem cell technologies forward through a more centralized effort, NCATS has launched the Stem Cell Translation Laboratory (SCTL) within the DPI.
The opioid crisis highlights the urgent need for novel non-addictive pain medications, as well as improved treatments for opioid addiction and overdose. There is a need for pharmacological agents directed at novel targets to test new therapeutic hypotheses, new clinic-ready drugs directed at those targets, and new testing systems with the potential to be more predictive of human clinical response than traditionally used models. Through the Helping to End Addiction Long-term (HEAL) Initiative, NCATS will focus on the development of human cell-based models of opioid misuse and addiction and of pain. The SCTL is a state-of-the-art research facility dedicated to addressing the scientific and technological challenges in the iPSC field. Specifically, the SCTL aims to develop a renewable supply of human cell-based models focusing on new patient-derived iPSC lines that give rise to specialized, functional nerve cells that are relevant for opioid misuse and addiction, and pain.
Purpose and Objectives
This Small Business Sources Sought notice seeks to determine eligible sources capable of achieving the essential features of this potential requirement. The purpose of this potential requirement is to obtain results from conjugation services with biochemical analysis on existing, government-ownded, scientific instruments including the Helios and Hyperion manufactured by Fluidigm Corporation, located at 7000 Shoreline Court Ste 100, San Francisco, CA 94080. The services requested in this order will be utilized by the SCTL scientists to continue project milestones and study the expression of markers of interest on the single-cell level in human pluripotent stem cells (hPSC) and their differentiated progeny, such as nociceptor cells, neurons, astrocytes, glial cells, trophectodermal/trophoblast cells and early progenitors committed to ectodermal, mesodermal and endodermal lineages.
The Helios is a mass cytometer that enables simultaneous detection of approximately 40 markers on a single-cell level in a suspension. This is achieved by binding antibodies to the antigens of interest that are conjugated to rare Lanthanide metals not normally found in biological systems. The suspension of cells stained with these antibodies is then introduced into the Helios instrument where it is ionized in a hot plasma and the ions of the metals are detected using a mass spectrometry detector. The Hyperion is a module capable of ablating tissues stained with metal-conjugated antibodies using a laser and the resulting plumes are then introduced into Helios for detection of its ion composition. Spatial information is recorded as the laser ablates the tissue spot-by-spot and line-by-line which allows for spatial reconstruction of the expression of the markers. The resulting data are highly dimensional images. The subject potential requirement includes services for the conjugation of Lanthanide metals to antibodies. These cell types that will be used in this study are derived from hPSC using differentiation protocols uniquely developed by the SCTL, which will put the SCTL at the forefront of high-dimensional marker research in pluripotent stem cells on the protein level.
Project Requirements
This Small Business Sources Sought notice seeks responses from qualified sources that are capable of providing the following salient service requirements of this potential government requirement deemed as the essential features needing to be achieved. Specifically, Offerors to this Small Business Sources Sought notice shall possess the capability to provide the following types of testing as essential requirements:
Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below.
The SCTL will purchase a total of 160 antibodies of their choice and will send them to Fluidigm. Fluidigm will then conjugate Lanthanide metals to these antibodies according to the design for each panel. A panel of antibodies is a collection of up to ~40 antibodies with each antibody carrying a different metal. This is important to ensure that each detected metal will only be associated with one antibody and hence a single marker of interest.
SCTL will identify antibodies to send to the vendor based on their specific targets. This selection will be done in batches (up to 38 antibodies per batch). The factors that the SCTL will consider when determining the antibodies are: Target outcomes derived from ongoing experiments (genomic data obtained from bulk and single-cell RNA sequencing), and the Effects specific antibodies have on the improvement of differentiation protocols. The vendor shall be required to perform the analyses with the "Maxpar Antibody Conjugation Service" on all 160 antibodies to enable single-cell researchers to dissect intracellular networks, using stable isotopes not normally found in biological systems to label antibodies and detect and quantify up to around 40 different parameters per cell.
The contractor shall be responsible for: receipt of antibodies, perform conjugation of Lanthanide metals to the antibodies, perform biochemical quality confirmation using inductively coupled plasma mass spectrometry (ICP-MS) and shipping of the antibodies back to the SCTL. Lanthanide metals are conjugated to antibodies using polymers in accordacne with the following steps:
1. preload the polymer with lanthanide
2. perform buffer exchange and partially reduce the antibody
3. purify the lanthanide-loaded polymer
4. purify the partially reduced antibody
5. retrieve the purified partially reduced antibody and lanthanide-loaded polymer
6. conjugate the antibody with lanthanide-loaded polymer
7. wash the metal-conjugated antibody
8. determine yield
9. recover and store the metal-conjugated antibody
Features and Benefits of this potential requirement shall include:
• The ability to detect and quantify up to around 40 channels simultaneously in a single cell results in exponentially greater information.
• Simultaneous phenotypic and functional assays lead to substantial improvement in the understanding of the heterogeneity of cell states.
• Removing the limitations of spectral overlap of fluorescence and the dysfunction of fluorophores inside cells allows the targeting of more intracellular proteins at a time.
• Barcoding enables multiplexed combinatorial multiparameter screens.
• Achieving a high-resolution proteomic snapshot or profile on the single-cell level distinguishes that cell from all others, revealing the heterogeneity of the sample.
Offerors submitting a response to this Small Business Sources Sought notice shall possess the ability to achieve the salient government essential features identified in this notice and provide documented evidence to be able to fully achieve the characteristicis of the subject requirement described herein.
GOVERNMENT RESPONSIBILITIES
The SCTL will be responsible for: making list of markers of interest; designing multiple panels of any number of and up to 37 antibodies, each to carry a different Lanthanide metal (this allows simultaneous detection without signal overlap); choosing suitable antibodies from vendors; purchasing the antibodies; sending a sufficient amount of each antibody (up to 200 µg) to the contractor for conjugation sending the antibodies in batches according to the panel designs of choice.
Period of Performance / Contract Type
The Period of Performance shall be for 12 months after effective date of contract award and contractor receipt of material to analyze. A Fixed-Price type of Purchase Order award not exceeding the Simplified Acquisition Threshold is anticipated for any contract resulting from this requirement. The anticipated award date is August 15, 2019.
Delivery/Warranty/Reporting
Delivery of at least 40µg of each resulting metal-conjugated antibody that will be analyzed shall be delivered to the Government. Offerors must indicate an estimated delivery time in full after receipt of an order and any other training or warranty considerations applicable. Inspection and acceptance will be performed at NCATS located at 9800 Medical Center Drive, Rockville, MD 20852. After the conjugation procedure concludes, each antibody's yield and quality will be reported to the SCTL, to include the following parameters: 1) yield; 2) concentration; 3) buffer formulation; 4) atoms/antibody ration by ICP-MS. The results derived from the mass cytometry experiments will be a part of scientific publications and they will be made available to the public on the SCTL public-facing internet website.
CAPABILITY STATEMENTS/INFORMATION SOUGHT
Interested parties are expected to review this notice to familiarize itself with the requirements of this project. Failure to do so will be at your firm's own risk.
Respondents must provide clear and convincing evidence of possessing the knowedge, skills, abilities and experience to successfully perform the requirements described in this announcement. Detailed prior experience in implementing similar requirements to the requirement described in this announcement must be clearly delineated in any response provided. Technical experience can include, but is not limited to: Experience (> 5 years) in the same or related field; access to all critical instrumentation necessary for this statement of work; and testing of the subject material. Respondents must provide clear and convincing documentation of their capability in providing analytical quality control and any other requirements and services specified in this notice. Respondents must provide a general overview of the respondents' opinions about the difficulty and /or feasibility of the potential requirement, and any information regarding innovative ideas or concepts.
The Respondent must also provide information in sufficient detail of the respondents' (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, or other related information.
The respondent must also provide their DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc.) pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements.
One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2" x 11" paper size, with 1" top, bottom, left and right margins, and with single or double spacing. The response is limited to fifteen (15) pages. The 15-page limit does not include the cover page, executive summary, CV's or references, if applicable.
The information submitted must be must be in and outline format that addresses each of the elements of the product requirement. A cover page and an executive summary may be included but is not required.
The response must include the respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses.
All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer. Facsimile responses are NOT accepted.
Respondents must reference the announcement number on all correspondence related to this Small Business Sources Sought notice. The response must be submitted to Hunter Tjugum electronically, at [email protected], and be received prior to the closing date specified in this announcement.
CONCLUDING STATEMENTS
Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.
Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).