SOURCES SOUGHT
66 -- Hydrogen Deuterium Exchange System
- Notice Date
- 5/14/2015
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- FDA1149120
- Archive Date
- 6/6/2015
- Point of Contact
- Regina R. Williams, Phone: (870) 543-7012
- E-Mail Address
-
regina.williams@fda.hhs.gov
(regina.williams@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), is conducting market research to support the Center for Biological Research (CBER) requirement for a Hydrogen-Deuterium Exchange System and Supporting Accessories. This is a Sources Sought Notice to determine the availability and capability of Small Business Manufacturers or Small Businesses capable of supplying a U.S. made product of a small business manufacturer or producer. This notice is for planning purposes only, and does not constitute an Invitation for Bids, Request for Proposals or Request for Quotation, or an indication the Government will contract for the items contained herein. This notice is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. The appropriate NAICS code for this acquisition is 334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. Statement of Work (SOW) Background/Scope Proteins are one of the vital component of any living cells. All but few functions of the cells are conducted by proteins. The structure of a protein is however dynamic, affected by the environment it is in. Most proteins are large molecules whose physical conformation is sensitive to chemical environments. Among many others, the studies of protein dynamics allow the following questions to be addressed: 1. How protein is folded under physiological conditions. For example, the structural transition of protein is related to drug-receptor binding, enzyme activity. 2. How protein aggregation of biologics is formed during biological product storage. These aggregates are expected to elicit unwanted immune reactions against the biologics. 3. How to develop a vaccine that could block the structural transition stages of the viral or bacterial protein, and how to monitor whether the pathogen could escape from inactivation through protein structural transition. The Facility Biotechnology Resources (FBR) recent development in protein structure dynamics is to use hydrogen-deuterium exchange to assess the conformation changes in a define environment. The rationale is that when protein structure or conformation changes, it allows hidden amino acids within a protein to be exposed to its medium, normally an aqueous buffered solution. When H2O in the buffered solution is partially replaced with D2O, there is a good possibility that hydrogen (H) in amino acids could be exchanged with deuterium (D) in a reversible manner. So, when there is no change in conformation or structure, the amino acids in a protein that could have H-D exchanges are those which are exposed to the medium and remain about the same. The reaction in exchange is rapid and dynamics. To capture the H-D changes, the time of exposure to D2O and the removal of D2O need to be controlled in a very precise way, and to maintain the D on amino acid the temperature of the system and the analysis in the mass spectrometer need to be under temperature control. Experiments of the kind could be handled manually, but the reproducibility of the results may vary from person to person and affected by the environment where the experiments are conducted. To avoid the variations due to personal and environmental errors, it is ideal to have an instrument that have robotic function and temperature control for D2O exposure, D2O removal, proteolytic digestion of proteins, and automatic Liquid Chromatography Mass Spectrometry (LC-MS) analysis of peptide mass (i.e., incorporation of D for H). Statement of Need The Facility for Biotechnology Resources (FBR) at CBER, FDA provides an array of services to CBER scientists. FBR recent acquisition of two high-end mass spectrometers enables FBR to provide protein characterization and other proteomic related applications. Since structure-encoded dynamic properties of proteins underlie their biological functions, it becomes important for FBR researchers to be able to assess protein structure and conformation changes in relation to their biological activities. One recent development technology in this line of research is to use hydrogen-deuterium exchange experiments, coupled with a mass spectrometer, to evaluate the dynamics of protein structure, taking advantage of high mass accuracy of a modern mass spectrometer. However, because replacement of hydrogen in a protein by deuterium is a rapid and reversible process, it is critical that accurate lengths of exposure to deuterium water, followed by rapid removal of deuterium water are reproducibly conducted under low temperature. To be able to fully utilize the high-end mass spectrometers, FBR requires Hydrogen-Deuterium Exchange System to expand the services to CBER and the Center for Drug Evaluation and Research (CDER) scientists. General Requirement ●The components and/or equipment shall be a newly manufactured, not used and refurbished, or previously used for demonstration. ●The entire system shall be warranted for parts and labor for a minimum of 12 months from date of installation acceptance. All warranty work shall be performed on-site at CBER, i.e., returning the equipment to the manufacturer is unacceptable. ●The system shall be delivered with all necessary supplies and accessories required for installation and start-up. ●The Contractor shall provide on-site (Government-site) operator familiarization training of the system to four (4) operators upon completion of installation. Such familiarization shall include system operations, optimization, and basic preventive maintenance procedures. ●The Contractor shall include all parts, travel, and labor to complete installation. Installation shall be performed and completed during normal duty hours (Monday through Friday, 8 am to 4:30 pm, Eastern Time). Technical Requirement At a minimum, the Contractor shall provide a Hydrogen-Deuterium Exchange System and Supporting Accessories that shall meet the following: 1. The system shall be supported by a mobile cart, capable of carrying out automatic H-D exchange experiments, including timed D2O incubation (labeling), quenching (remove labeling agent), protease (e.g., trypsin) digestion, products delivery to the coupled mass spectrometer for mass analysis. 2. The system shall be self-sufficient with required software programs controlling each step necessary for H-D exchanges, and integrated with the software programs controlling the following mass spectrometers: Thermo Electron North America Orbitrap Fusion, Serial Number FSN10307 or Q Exactive, Serial Number 02092P. 3. The system shall have the following performance specificities: a. Capacity: Up to 20 samples and 100-timepoints per experiment. There shall be positions for 10x 10 ml reagent vials. b. Temperature controlled zones: 2x independently controlled non-condensing Peltier Tray holders with total capacity as described above; c. Cooled chromatography chamber: with solvent pre-conditioning cooler; d. 3x valve drives and Ultra High Pressure Liquid Chromatography (UHPLC) valves: for controlling LC flow for digestions and trapping followed by elution to Mass Spectrometer. e. Temperature range: 0 degrees Celsius to ambient f. Temperature control: +/- 0.1 degrees Celsius g. Volume range: The system shall be equipped with 2 syringe tools: 10 microliter and 250 microliter. h. Labeling Times: 10 seconds up to 24 hours. Labeling accuracy: approximately 2 seconds 4. Power requirement for 120 VAC, 60 Hz 5. The Contractor shall be responsible for installation of the system by integration of the H-D exchange instrument with the existing mass spectrometer (an Orbitrap Fusion or Q Exactive). Period of Performance Ninety (90) calendar days after contract award. Place of Performance White Oak Campus FDA/CBER 10903 New Hampshire Avenue Building 72 Silver Spring, MD 20933 The respondent to this source sough shall furnish sufficient technical information necessary for the Government to conclusively determine its capability to provide products/services and components meeting the technical requirements identified above. At a minimum, responses shall include the following: Business name, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address (Provide this same information if responding to provide a product manufactured by another firm); Sufficient descriptive literature that unequivocally demonstrates that offered products and services meet or exceed above specifications. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement. Three (3) years of past performance information for the manufacture and/or sale of same or substantially similar items to include date of sale, description, dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include DUNS number and size status) if not the respondent. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. The government is not responsible for locating or securing any information, not identified in the response. Interested parties shall respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before May 22, 2015 by 12:00 PM (Central Time in Jefferson, Arkansas) at the FDA/OO/OFBA/OAGS/DAP, Field Operations Branch, Attn: Regina Williams, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502 or email regina.williams@fda.hhs.gov. Reference FDA1149120. 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)."
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