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FBO DAILY - FEDBIZOPPS ISSUE OF AUGUST 26, 2016 FBO #5390
SOLICITATION NOTICE

Q -- Plasmodium Falciparum Vps34: X-Ray Crystallography Program

Notice Date

8/24/2016
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

541380 — Testing Laboratories
 

Contracting Office

Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 3155, MSC 9593, Bethesda, Maryland, 20892, United States
 

ZIP Code

20892
 

Solicitation Number

HHS-NIH-NIDA-SSSA-NOI-2016-547
 

Archive Date

9/18/2016
 

Point of Contact

Stacey M Polk,
 

E-Mail Address

spolk@nida.nih.gov
(spolk@nida.nih.gov)
 

Small Business Set-Aside

N/A
 

Description

INTRODUCTION 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. This acquisition is being conducted in accordance with the procedures of FAR Part 13--Simplified Acquisition Procedures and FAR Part 12--Acquisition of Commercial Items. The solicitation number is HHS-NIH-NIDA-SSSA-NOI-2016-547 and the solicitation is issued as a PRE-SOLICITATION, NOTICE OF INTENT, to award a contract on a noncompetitive basis to Xtal Biostructures, Inc located at 12 Michigan Drive Natick, MA 01760. REGULATORY & STATUTORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13--Simplified Acquisition Procedures, Subpart 13.106-1, only one responsible source and no other supplies or services will satisfy agency requirements, and FAR Part 12--Acquisition of Commercial Items and is NOT expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13--Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6--Competition Requirements. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-89-1, dated August 15, 2016. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The associated NAICS code for this requirement is 541380 with size standard of $15 million. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The non-competitive determination is based upon the market research conducted as prescribed in FAR Part 10--Market Research. A Sources Sought Notice was posted to FedBizOpps referencing the detailed requirements and no responses were received from other vendors. The results of market research concluded that only Xtal Biostructures, Inc. has specific experience with lipid kinases, are familiar with the paper Shaping Development of Autophagy Inhibitors with the Structure of the Lipid Kinase Vps34 and the key issue of the N-lobes precense. This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. DESCRIPTION OF REQUIREMENT Purpose and Objectives NCATS has a need for the production, purification and X-ray structure determination of Plasmodium falciparum Vps34 in complex with a small molecule ligand to provide insight on efficacy across many cancers and will help progress and provide critical scientific guidance on projects that NCATS has been working on for many years. Project Description Vendor shall provide the following: Scope of Work Phase 1: Construct Evaluation: Two weeks •produce modified expression constructs to evaluate the suitability of the selected forms in an E. coli expression system. The utility of various tags may be evaluated •The resultant vectors will be transformed into a suitable E. coli strain. Selected clones will be tested for expression, with optimization of induction and culture conditions to evaluate for soluble expression •The expression levels, solubility, and stability of the various constructs and expression conditions will be evaluated by SDS-PAGE and Western blot analysis. Phase 2 : Pilot Scale purification: Two weeks •two constructs (and expression systems) will be selected to evaluate and develop a purification process for each of the two constructs. •If an E. coli expression system is utilized for generation of the protein, the vendor will produce a 2 L culture for use in the method development. If a yeast-based expression is selected, the vendor will utilize material available from NCATS, or produce a suitable amount. •The protein will be characterized by SDS-PAGE, MALDI-TOF mass spectrometry, size-exclusion chromatography (SEC), and thermal stability shift. •If requested, portion of the resultant materials will be supplied to NIH NCATS for confirmation of quality and activity Phase 3 : Thermal Shift assay confirmation of ligand binding: Two weeks •The vendor will develop a TSA for the provided protein and characterize the melting temperature (Tm) of the initial material. •The vendor will perform a protein titration in the initial purification buffer to identify a protein concentration suitable for TSA screening in a 384-well plate format •Each protein (or protein complex) will be evaluated in a thermal stability assay screen to evaluate the buffer conditions and additives that would influence the stability and signal for the protein •The vendor will evaluate a control compound (a known binder), if available, and the test compound in the buffer conditions for optimization of the TSA screen. A six-point concentration series will be run to evaluate to binding interaction. • Phase 4 : Bulk protein production and purification: Two months •Based on yields established in Phase 2, expression cultures will be produced to allow yields of >10 mg of each protein with purity ≥95%. •The purification protocol established in Phase 2 will be scaled up to process the material provided •The protein will be characterized by SDS-PAGE, MALDI-TOF mass spectrometry, and SEC Phase 5 : Co-crystallization screening and optimization: Two months •Based on a review of the available information, the target protein and the top set of ligands will be selected for the initial co-crystallization efforts •Based on the binding interaction data, experimental conditions will be designed for the production of the complex on the milligram scale for use in the crystallographic studies •The protein-ligand complex will be screened for crystallization with sparse-matrix and systematic grid screening approaches. •Conditions that initially produce microcrystals will be identified •Selected conditions will be optimized to improve the crystal size and quality. •Based upon the forms crystallized and the priority of interest, the vendor will obtain approval for specific co-crystal(s) to be evaluated and pursued for full structure determination. •Crystal of suitable size will be harvested, transferred into suitable cryoprotection solutions, and frozen for transport to a synchrotron X-ray facility. Phase 6: X-ray structure determination: Two months X-ray diffraction analysis and data collection: •For each targeted structure, multiple crystals will be screened for X-ray data quality. •If the X-ray diffraction is of sufficient quality (≤2.8 Å resolution and good diffraction lattice properties) then a complete X-ray data set will be obtained for the best crystal. Initial data processing: •Complete data sets will be indexed and scaled, followed by space group evaluation, molecular replacement, and generation of initial electron density maps •Processed data sets will be evaluated according to statistical values and interpretation of the initial electron density map Refinement, model building, analysis, and reporting: •If the processed data and electron density maps are of sufficient quality and resolution, and the bound ligand is observed, then multiple rounds of refinement and model building will be performed to obtain a final model. •The resultant model will be analyzed, and both the structure and results presented to NIH NCATS in a summary document, along with structure files Delivery/Period of Performance Delivery of final results within eight months ARO Contract Type A firm fixed price purchase order within the Simplified Acquisition threshold is anticipated. Payment shall be remitted using Electronic Funds Transfer on a NET30 basis. RESPONSE INSTRUCTIONS Responses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. Offerors must provide both 1) a technical response and 2) a separate price quote. 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; and maintenance availability. APPLICABLE TERMS AND CONDITIONS INCORPORATED BY REFERENCE The following FAR clauses and provisions shall apply to this solicitation: 1.All Offerors MUST be actively registered in the System for Award Management (SAM) www.sam.gov. 2.FAR clauses 52.212-4, Contract Terms and Conditions - Commercial Items (May 2015) and 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (June 2016) apply to this acquisition. In addition, the Dun & Bradstreet Number (DUNS), 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." CLOSING STATEMENT All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency. All responses must be received by the closing date of this announcement must reference solicitation number HHS-NIH-NIDA-SSSA-NOI-2016-547. Responses shall be submitted electronically to Stacey Polk, Contract Specialist, at Stacey.polk@nih.gov. U.S. Mail and Fax responses will not be accepted.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-01/HHS-NIH-NIDA-SSSA-NOI-2016-547/listing.html)
 

Place of Performance

Address: National Institutes of Health, 9800 Medical Center Drive, Rockville, Maryland, 20850, United States

Zip Code: 20850
 

Record

SN04239962-W 20160826/160825000124-2c7bf8c2d1f330c8fa6ae322bce6ae97 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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