75N95023Q00590

Post Date/ Solicitation Issue Date

August 16, 2023 12:00 pm

Closing Response Date

August 21, 2023 3:00 pm

Proposed Award Date

August 31, 2023 12:00 pm

Project Title

Service to generate three (3) CRISPR knockout (KO) and knockin (KI) versions of the ColQ and Dok7 genes in C2C12 secondary myoblast cell line for the PAVE-GT Project.

Contracting Office

National Center for Advancing Translational Sciences (NCATS)

Small Business Size Standard

1000 Employees

FPDS Classification Code

6505

Estimated Period of Performance

10-14 weeks from date of award

Competition Status

Non-Competitive

Single-Sole Source Determination

Non-Competitive (Single-sole Source (Including brand-name)) Determination:
This notice of proposed acquisition is posted as an intent to award a purchase order on a non-competitive basis to Codex BioSolutions Inc, 401 Professional Dr, STE 160, Gaithersburg, MD, 20879 Phone: 301-538-8802

The Non-Competitive (Single-sole Source (Including brand-name)) Determination is based upon the market research conducted. Specifically, only one source is capable of providing the supplies or services required pursuant to FAR 13.106-1(b)(1)(i), only one source is reasonably available.

Background/Description of Requirement

Description of Requirement:

The National Center for Advancing Translational Sciences (NCATS) requires a service agreement to generate three (3) CRISPR knockout (KO) and knockin (KI) versions of the ColQ and Dok7 genes in C2C12 secondary myoblast cell line for the PAVE-GT Project.

Background Information and Objective:

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, conducting, supporting, and making medical discoveries that improve people’s health and save lives. The National Center for Advancing Translational Sciences (NCATS) is a part of the NIH, with a mission 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.

NCATS is applying its collaborative translational science model to transform understanding, diagnosis, and treatment of rare diseases. NCATS’ fundamental approach is to shift from considering each rare disease in isolation to identifying and developing treatments for rare diseases based on their commonalities. NCATS invests resources and expertise at the points where research is most difficult and therefore often abandoned. Translation is a team sport. The NCATS Division of Preclinical Innovation (DPI), Office of Rare Diseases Research (ORDR), and Office of Strategic Alliances (OSA) work together to achieve PaVe-GT objectives to test a translational science hypothesis: Can researchers significantly increase the efficiency of gene therapy trial startup by using the same capsid and manufacturing methods for different AAV gene therapies, thereby minimizing redundancies in the preclinical development of gene therapies for extremely rare diseases?

Approximately 7,000 rare diseases affect 25 million people in the United States, but only about 5 percent of rare diseases have a treatment approved by the U.S. Food and Drug Administration (FDA). Fortunately, it is becoming increasingly possible to develop gene therapies for rare diseases. A rapidly maturing therapeutic platform — adeno-associated virus (AAV) gene therapy — holds great promise for many rare diseases. The goal of NCATS’ PaVe-GT pilot program is to test whether we can significantly increase the efficiency of gene therapy trial startup by using a standardized process, with the same capsid and manufacturing methods, for four different rare diseases. Importantly, TDB-Biology group will test this hypothesis in a transparent manner so that results, documents, and learnings resulting from the program will be made publicly available and can therefore be used to benefit subsequent AAV gene therapy efforts. Therefore, the TDB Biology group has a need for services for generating

three (3) CRISPR knockout (KO) and knockin (KI) versions of the ColQ and Dok7 gene in the C2C12 secondary myoblast cell, which will then be used by the TDB-Biology group to develop functional assay for the PAVE-GT program.

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:

Specific Requirements:

 

• The Contractor shall generate three (3) C2C12 cell lines using the  CRISPR method ( ColQ knockout, Dok7 knockout and Dok7 knockin) and shall provide frozen vials of immortalized cells per service.
• The Contractor shall conduct quality control (QC) tests to verify that the differentiation capacity of the generated C2C12 lines is maintained.
• The Contractor shall conduct a qPCR and western blot analysis on transgene expression.

The Contractor shall assess the morphology of the cell lines and test for microbial contaminants.

Government Responsibilities:

In order to generate the knockout (KO) and knockin (KI) C2C12 lines, NCATS will provide the following to the Contractor shortly after purchase order award.

1.  2 vials of frozen primary cells (>10^6 cells per vial).
2.  500ml differentiation medium for testing the differentiation capacity of the generated C2C12 lines.
3. Cell culture protocol

Delivery or Deliverables:

The Contractor shall deliver two vials of frozen cells per service. Each vial shall have at least 1x10^6 cells which shall be delivered to NCATS at the following address.

Mitali Tambe, Biologist, NCATS/TDB-Biology group

BLDG C / RM 317W, 9800 Medical Center Dr, Rockville, MD 20850

Reporting Requirements:

 

The Contractor shall deliver a QC report for the generated immortalized cell lines by the expiration date of the purchase order. This report shall include the qPCR analysis of transgene, an assessment of the cell morphology, assessment for differentiation capacity, and the test results for microbial contaminants for the generated immortalized cell lines. The report shall be delivered to Mitali Tambe electronically at mitali.tambe@nih.gov.

Data Rights:

All data and materials used, produced, and analyzed is sole property of the government. The Contractor has no right to use or generate for any other contractor the constructs provided to

Section 508- Electronic and Information Technology Standards:

The Contractor’s reports shall comply with HHS Section 508 requirements for file accessibility: https://www.hhs.gov/web/section-508/making-files-accessible/index.html.

See Attachment 1 – Statement of Work.

 

QUOTER TERMS AND CONDITIONS: (To be completed by the Offeror):

1. Period of Performance OR Delivery Date After Receipt of Order:
2. Shipping Point (F.O.B. OR Destination):
3. Payment Discount Terms:
4. Open Market; GSA FSS Contract Number; Other Government Agency (OGA) Contract Number, Government-wide Agency (GWAC) Contract Number; or National Institute of Health (NIH) Blanket Purchase Agreement (BPA) Number:
5. DUNS No:
6. Name of Company:
7. Street Address, City, State, Zip code:
8. Name of Person Authorized to Provide Quote:
9. Telephone Number and Email Address of Person Authorized to Provide Quote:

CONTRACT TYPE:

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 08/31/2023

ADDITIONAL TERMS AND CONDITIONS, PROVISIONS, AND REPRESENTATIONS

FAR 52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998)

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es): www.acquisition.gov

(End of provision)

FAR 52.252-2 Clauses Incorporated by Reference (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): www.acquisition.gov

(End of clause)

The FAR provisions and clauses are incorporated by reference and are provided in full text at https://www.acquisition.gov/

1. 1. 1. 1. The provisions of FAR Clause 52.212-1 Instructions to Offerors—Commercial Items (NOV 2021) is applicable to this solicitation.
         2. The provisions of FAR Clause 52.212.2 Evaluation—Commercial Items (NOV 2021) is applicable to this solicitation. The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award a purchase order from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes:
            1. 1. 1. 1. Technical capability of the service offered to meet the Government requirement;
                     2. Price; and
                     3. Past performance [see FAR 13.106-2(b)(3)].
         3. The provisions of FAR Clause 52.212-3, Offeror Representations and Certifications—Commercial Items (NOV 2021), is applicable to this solicitation.
         4. The provisions of FAR Clause 52.212-4, Contract Terms and Conditions—Commercial Items (NOV 2021) with Addenda: Stop Work Order, FAR Clause 52.242-15 (AUG 1989) is applicable to this solicitation.
         5. The provisions of FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items (JUNE 2023) is applicable to this solicitation.  See attachment.  

In addition, the following FAR provisions and clauses are applicable to this solicitation and incorporated by reference:

52.204-7 System for Award Management (OCT 2018),

52.204-13 System for Award Management Maintenance (OCT 2018),

52.204-16 Commercial and Government Entity Code Reporting (AUG 2020),

52.204-18 Commercial and Government Entity Code Maintenance (AUG 2020).

The clause at HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015)

The following provisions and clauses apply to this acquisition and are incorporated as an attachment. Offerors MUST complete the provision at 52.204-24 and 52.204-26 pursuant to FAR 4.2103 Procedures and submit a completed copy as a separate document with their quotation. 

1. FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (NOV 2021)
2. FAR 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Aug 2020)
3. FAR 52.204-26, Covered Telecommunications Equipment or Services-Representation (Oct 2020)
4. NIH Invoice and Payment Provisions (Rev. 2/10/2021)

Period of Performance: The anticipated period of performance is 10-14 weeks from the date of award. Inspection and acceptance will be performed at NCATS located at 9800 Medical Center Drive, Rockville, MD 20852.  A firm fixed price type order is anticipated to be awarded as a result of this RFQ.

SUMMARY STATEMENT:

Responses to this notice must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service.  The response shall include: the unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision.  Such factors may include: past performance; special features required for effective program performance; trade-in considerations; probable life of the item selected as compared with that of a comparable item; warranty considerations; maintenance availability; and environmental and energy efficiency considerations.