SOLICITATION NOTICE
65 -- Development of JAG-1 HiBiT LX-2 hepatic stellate cell (HSC) line and development of NOTCH2 reporter cell line and functional assay
- Notice Date
- 5/4/2023 6:13:07 AM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NCATS BETHESDA MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N95023Q00266
- Response Due
- 5/12/2023 11:00:00 AM
- Archive Date
- 05/27/2023
- Point of Contact
- Morgen Slager
- E-Mail Address
-
morgen.slager@nih.gov
(morgen.slager@nih.gov)
- Description
- (i)� �This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. (ii)� The solicitation number is 75N95023Q00266 and the solicitation is issued as a request for quotation (RFQ). This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13�Simplified Acquisition Procedures; �and FAR Part 12�Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold. THIS IS A NON-COMPETITIVE (NOTICE OF INTENT) COMBINED SYNOPSIS SOLICITATION TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).� The National Institute on Drug Abuse (NIDA), Office of Acquisition (OA), on behalf of The National Center for Advancing Translational Sciences (NCATS), Therapeutic Development Branch (TDB) intends to negotiate and award a Firm Fixed Priced contract without providing for full and open competition (including brand-name) to Promega Corp, 2800 Woods Hollow RD, Fitchburg, WI 53711-5300 for development of JAG-1 HiBiT LX-2 hepatic stellate cell (HSC) line and development of NOTCH2 reporter cell line and functional assay. This acquisition is conducted as non-competitive for a commercial item or service and is conducted pursuant to FAR 13.106-1(b)(1). The essential characteristics of the development of JAG-1 HiBiT LX-2 hepatic stellate cell (HSC) line and development of NOTCH2 reporter cell line and functional assay that limit the availability to a sole source are utilization of the HiBiT and NanoLuc technologies for their development. Promega is the sole developer and patent holder of the NanoLuc and HiBiT technologies. Only this suggested source can furnish the requirements, to the exclusion of other sources. (iii)� The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2023-02 dated March 16, 2023. (iv)� The associated NAICS code 325414 � Biological Product (except Diagnostic) Manufacturing and the size standard in number of employees is 1,250. (v)� This requirement is for the development of JAG-1 HiBiT LX-2 hepatic stellate cell (HSC) line and development of NOTCH2 reporter cell line and functional assay. (vi)������ Background: Promega is a cutting edge enzyme and molecular biology company and is the sole developer of the HiBiT and NanoLuc technologies that will be used to produce both cell lines. The NanoLuc technology is the newest addition to the family of luciferase enzymes commercially available for bioluminescence applications. Luciferase enzymes produce light when catalyzing their specific substrates, making them useful as tags for detection of protein expression or interaction. The small, bioengineered NanoLuc enzyme displays a specific activity over 150-fold higher than other luciferases, enabling very sensitive signal detection. The genetic code for this enzyme can be edited into the genome of a specific cell type and its expression can be controlled by a chosen transcription factor, enabling the detection of signaling events in the cell. In our case, an RBP-Jk-RE/Luc2P reporter gene will be cloned into one cell line, enabling the detection of JAG1-NOTCH2 signaling. Under typical conditions, JAG1 binds NOTCH2, initiating the cleavage of NOTCH2 and the translocation of its intracellular domain to the nucleus where it binds to RBP-Jk-RE and MAML1 to form a transcription complex and activate NOTCH controlled gene expression. In our system line an increase of JAG1 in the effector cell line should increase NOTCH2 cleavage in the target cell line that contains the RBP-Jk-RE/Luc2P gene, and therefore initiate the expression of NanoLuc which we would detect by measuring the bioluminescence of our cells. The HiBiT technology further improves upon the NanoLuc system by splitting the NanoLuc protein into two pieces (HiBiT and LgBiT). The HiBiT tag is small enough for the use CRISPR/Cas9 editing to add it to endogenous genes, allowing for the detection of the increase or decrease in the expression of specific protein, such as JAG1. Our primary screen, used the LX-2 cell and measured the small molecule induced increase in JAG1 mRNA. This secondary assay would use the same cell line but would edit the JAG1 gene to add the HiBiT tag, allowing for the detection of JAG1 protein expression through the addition of the the LgBiT and measurement of biolumenescence. The objective of this project is the creation of these two reporter cell lines to enable TDB to select hit molecules that can increase JAG1-NOTCH2 signaling for in vivo testing. Molecules that further show efficacy in in vivo testing will be submitted for IND for the treatment of ALGS. Purpose: The purpose of this requirement is for development of JAG-1 HiBiT LX-2 hepatic stellate cell (HSC) line and development of NOTCH2 reporter cell line and functional assay. Project 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. Specific Requirements: JAG1 HiBiT LX-2 HSC cell line development: 1. Design and test up to 2 guide RNAs to insert HiBiT either immediately upstream of the stop codon of the JAG-1 CDS via CRISPR in LX-2 HSC cells (CRL-2957), or immediately after the initiator methionine (UniProt ID P78504). 2. Screen pools for HiBiT luminescence and knock in (KI) efficiency. Development of a NOTCH2 functional assay and cell line: Two cell lines must be developed to validate this assay: 1. The target cell: JAG1 expressing, should have no expression of other NOTCH ligands 2. The effector cell: co-expression of NOTCH2 and RBP-Jk-RE/Luc2P reporter gene. Should not express other NOTCH receptors Milestone 1: NOTCH2 PoC in two cell line models. 1. Generating JAG1 stable pools: a. Cells will be transfected with JAG1 expression vector, drug selected and FACS sorted into low-medium and medium-high expression pools. b. Pools will be expanded for use in downstream assay development 2. Generating HEK293 pools by co-transfecting NOTCH2 receptor and RBP-Jk-RE/Luc2P reporter gene: a. Cells will be transfected with NOTCH2 and FACS sorted b. NOTCH2 positive cells will be transfected with RBP-Jk-RE/Luc2P reporter gene and drug selected. c. Pools will be expanded for use in downstream assay development 3. Functional assay development: a. Plate JAG1 expressing target cells and NOTCH2/RBP-Jk-RE/Luc2P expressing effector cells in 96 well plates. �i. Use cells that do not express JAG1 or other NOTCH ligands as negative control to show signal production is dependent on the expression of JAG1 �ii. Use different target:effector cell ratios b. Detect reporter gene exression at 6h to overnight post palting Milestone 2: NOTCH pathway effector cell line development. 1. Selection of single effector cell background from previous milestone data 2. Clone selection based off function assay using target/effector cell pools 3. Top clones will be selected using function assay as previously described 4. Final clones will be selected using LX-2 HSC cells pre-treated with TGF-B (72-96 hours post-treatment) 5. Up to three top clones will be cryopreserved as part of deliverables 6. Original JAG1 target cell pool will be cryopreserved as part of deliverables Deliverables: 1. Data report 2. Up to three top clones of Notch2 pathway Effector cells 3. JAG-1/CHOK1 pool Cell Line Specifications include: 1. Two (2) vials at ~5x106 cells/ml/vial. Frozen cells will pass the following criteria: 2. Cells per vial: ~5x106 3. Free of bacteria (visual inspection) 4. Free of mycoplasma (Lonza MycoAlert) (vii)���The Government anticipates award of a firm fixed-price contract for this acquisition, and the anticipated period of performance is: The development of the JAG1 HiBiT LX-2 cell line will take 8 - 10 weeks. The development of the NOTCH2 reporter line will be split into two milestones: 1) Milestone 1: NOTCH2 PoC in two cell line models (10 -13 weeks) 2) Milestone 2: NOTCH2 effector cell line development (8 - 10 weeks) (viii)� �The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), applies to this acquisition. 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 these addresses:� https://www.acquisition.gov/browse/index/far �� https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html �� � (End of provision) The following provisions apply to this acquisition and are incorporated by reference: FAR 52.204-7, System for Award Management (Oct 2018) FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020) FAR 52.212-1, Instructions to Offerors-Commercial Items (Nov 2021) FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2021) FAR 52.222-48, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Certification (May 2014) HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015) The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. 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 these addresses: https://www.acquisition.gov/browse/index/far ��� https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html � (End of clause) The following clauses apply to this acquisition and are incorporated by reference: FAR 52.204-13, System for Award Management Maintenance (Oct 2018) FAR 52.204-18, Commercial and Government Entity Code Maintenance (Aug 2020) FAR 52.212-4, Contract Terms and Conditions-Commercial Items (DEC 2022). Addendum to this FAR clause applies to this acquisition and is attached. FAR 52.217-9, Option to Extend the Term of the Contract (Mar 2000). HHSAR 352.239-74, Electronic and Information Technology Accessibility (December 18, 2015) The following provisions and clauses apply to this acquisition and are attached in full text. Offerors MUST complete the provisions at 52.204-24 and 52.204-26 and submit completed copies as separate documents with their proposal. FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021) FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (Jan 2022) NIH Invoice and Payment Provisions (APR 2022) (ix)� 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: a. Technical capability of the item offered to meet the Government requirement; b. Price; and c. Past performance [see FAR 13.106-2(b)(3)]. (x)� �The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2021), with its offer. If the offeror has completed FAR clause 52.212-3 at www.sam.gov, then the offeror does not need to provide a completed copy with its offer. (xi)� The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items (Nov 2021), applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached. (xii)��There are no additional contract requirement(s) or terms and conditions applicable to this acquisition. (xiii)� The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xiv)� Responses to this solicitation must include sufficient information to establish the interested parties� bona-fide capabilities of providing the product or service. The price quote shall include: 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. The Unique Entity ID (UEI), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. All offers must be received by 2:00p.m., Eastern Daylight/Standard Time, on Friday May 12, 2023, and reference solicitation number 75N95023Q00266. Responses must be submitted electronically to Morgen Slager, Contract Specialist at morgen.slager@nih.gov. Fax responses will not be accepted.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/9029e000e5574be7a47975b535a413f7/view)
- Place of Performance
- Address: Rockville, MD 20850, USA
- Zip Code: 20850
- Country: USA
- Zip Code: 20850
- Record
- SN06672719-F 20230506/230504230122 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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