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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 541990- All Other Professional, Scientific and Technical Services with associated small business size standard of $15.0 million.
BACKGROUND
The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) was officially established in fiscal year 2012 to transform the translational science process so that new treatments and cures for disease can be delivered to patients faster. NCATS, one of 27 Institutes and Centers (ICs) at NIH, strives to develop innovations to reduce, remove or bypass costly and time-consuming bottlenecks in the translational research pipeline in an effort to speed the delivery of new drugs, diagnostics and medical devices to patients.
To establish and move stem cell technologies forward through a more centralized effort, NIH has launched the Stem Cell Translation Laboratory (SCTL) within NCATS. Part of the NIH Common Fund, the goal of the SCTL is to bring iPSC technology closer to clinical application, drug discovery and regenerative medicine. Through the SCTL, NCATS will provide researchers across various disciplines and organizations with the ability to establish collaborations to advance the translation of regenerative medicine applications.
PURPOSE AND OBJECTIVES
SCTL seeks the generation of seven (7) human pluripotent stem cell reporter lines via lentiviral delivery. The purpose of this potential requirement is for SCTL to obtain contractor results of generating transgenic cell lines carrying a Government-provided selected promoter driving an emGFP reporter gene. After antibiotic selection of cells carrying the integrated lenti vector, the resultant pools will be expanded and further characterized.
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. Offerors to this Sources Sought notice shall possess the capability of achieving the following general 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. Transgenic iPSC line human pluripotent stem cell generation shall involve contractor services performing the following services:
Task 0: PSC Characterization:
1. Cell expansion for testing
2. Cells will be tested for normal karyotype
3. Pluripotency will be confirmed by running a Taqman hPSC Scorecard assay or pluripotency assays.
Task 1: Gene Synthesis and Subcloning into pLenti Vector (Project IDs 2018AAAGFC, 2018AACAPC and 2018AACVMC):
1. The promoter will be synthesized and the DNA will cloned into a pLenti vector carrying a emGFP reporter.
2. The insert will be sequence verified to ensure no mutations have occurred
3. Provide an aliquot of DNA for transient testing in a relevant cell type (provided by the cell biology team)
4. Plasmid preparation and transfer to lentivirus production team
5. Milestone 2 would continue after functional confirmation by the Government.
Task 2: Lentivirus Production and Concentration:
Starting material: Purified Plasmid DNA (pLenti Expression Construct)
1. Generate Lentivirus stocks.
2. Concentrate Lentivirus stocks (if needed).
Task 3: Antibiotic Kill Curve
1. Establish optimal antibiotic concentrations for cell line selection and generation.
2. Thaw and culture cell line.
3. Perform antibiotic selection kill curves
Task 4: Cell Line Generation
1. Transduce the cells with the expression lentivirus created in the previous task and generate an antibiotic-resistant pool of cells for the target.
2. Desired parental cell line will be transduced with the lentivirus according to standard protocols.
3. The cells will be placed under antibiotic selection for >3 weeks.
3a. Antibiotic selected pools will be tested for PCR amplification of the insert or other methods of detection (TBD).
3b. Selected cells will be expanded for banking
3c. Cells will be tested for mycoplasma
3d. Provide three (3) vials of 1x106 cells for shipping
Task 5: PSC Characterization
1. Cell expansion for testing.
2. Cells will be tested for normal karyotype.
3. Pluripotency will be confirmed by running a Taqman hPSC Scorecard assay or pluripotency assays per agreement with the Government.
Period of Performance
Project Initiation Date: receipt of purchase order and the compounds
Project Completion Date: 30 weeks after receipt of the compounds
Anticipated timeframe for each task includes the following:
Task 0: 4-6 weeks
Task 1: 10 weeks
Task 2: 2-3 weeks
Task 3: 2-3 weeks
Task 4: 4-6 weeks
Task 5: 4-6 weeks
GOVERNMENT RESPONSIBILITIES
NCATS will supply Promoter(s) of Interest Sequence(s) and confirmation of synthesis plan as well as the Human iPSC line. "Task 0: Starting Material" specifically inlcudes the following:
1. Annotated Genomic DNA file with the promoter sequence.
2. Client-supplied Cell Line (3 vials containing 1x10e6 cells/vial) Karyotype information.
3. Instructions on growth requirements.
4. Certification that the original cell line is mycoplasma free.
5. Certification that the original cell line is free of retrovirus, Lentivirus, Adenovirus, and Hepatitis B virus infection.
6. Recovery of iPSC, mycoplasma testing and generation of a small back up bank.
DELIVERY OR DELIVERABLES
Reporting of results must be delivered electronically to NCATS upon completion of the project. Specifically, the contractor shall deliver:
Task 0: PSC Characterization: Project Report or Certificate of Analysis.
Task 1: Gene Synthesis and Subcloning into pLenti Vector: Purified Plasmid DNA (pLenti Expression Construct)
Task 2: Lentivirus Production and Concentration: Purified Plasmid DNA (pLenti Expression Construct) Milestone report Workplan
Task 3: Antibiotic Kill Curve: Host Cells Expansion and Antibiotic Kill Curve Milestone Report
Task 4: Cell Line Generation: Report and 3 vials of cells
Task 5: PSC Characterization: Project Report or Certificate of Analysis.
CAPABILITY STATEMENT / 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 past experience in implementing similar requirements to the requirement described in this announcement must be clearly delineated in any response provided. 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, and 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 ten (10) pages. The 10-page limit does not include the cover page, executive summary, CV's or references, if requested.
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.
The response MUST reference the solicitation number and be submitted electronically to Mr. Hunter Tjugum at [email protected] prior to the closing date specified in this announcement. The response must be received on or before the closting date/time 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).