SOURCES SOUGHT
A -- Hematological Protein Characterization Services
- Notice Date
- 7/16/2015
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- 1151450
- Archive Date
- 8/15/2015
- Point of Contact
- Sondea R Blair, Phone: 8705437469
- E-Mail Address
-
sondea.blair@fda.hhs.gov
(sondea.blair@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION This is a sources sought to determine the availability and capability of small businesses in providing Hematological Protein Characterization Services. The associated North American Industry Classification System (NAICS) Code is 541711-Research and Development in Biotechnology; Small Business Size Standard is 500 employees. Part I: General Information (Introduction/Background/Scope) The U.S. Food and Drug Administration (FDA), Center for Biologics Research and Evaluation (CBER), Division of Hematology (DOH) performs experimental life-science/biomedical research on various proteins involved in blood coagulation. DOH requires comprehensive characterization of post-translational modifications of recombinant human coagulation Factor IX (FIX). The characterization includes Nitrogen Linked Glycosylation (N-glycan) profiling, activation peptide analysis, Gamma-Carboxyglutamic Acid-Rich (Gla) domain mapping and peptide mapping using endoprotease C-Terminal side of Lysine Amino Acid (Lys-C). These analyses, especially activation peptide analysis and Gla-domain mapping, require expertized knowledge and experience on coagulation factors, in addition to post-translational modification analysis. The biological activity of FIX depends on a complex molecular structure that contains several posttranslational modifications. These include modification of numerous glutamate (Glu) residues to γ-carboxyglutamate (Gla), in the Gla domain. The Gla domains are a common feature of several coagulation proteins and confer affinity to calcium ions, which is critical to the protein function. In addition, FIX undergoes glycosylation, phosphorylation, and sulfation particularly in the activation peptide. Correct cleavage of the activation peptide is crucial for the generation of the active factor IX and is dependent in part on its post-translational modifications. The results of these analyses will be critical in the study of recombinant therapeutic proteins. Part II: Work Requirements A. Hematological Protein Characterization Services The contractor will be provided sixteen (16) samples at the government's expense within 14-calendar days of contract award, and shall complete each of the following tests inclusive of complete sample preparation, desalting, buffer exchange, detergent removal, dialysis, and protein concentration: o N-glycan profiling o Activation peptide analysis o Gla-domain mapping o Peptide mapping o Analysis of the 35 amino acid residue activation peptide by using specifically designed peptide mapping and liquid chromatography - tandem mass spectrometry (LC-MS/MS) method. o Analysis of the twelve Gla residues within 34 amino acids stretch by using peptide analysis method specifically designed for Gla domain analysis. o Complete amino acid sequence of the protein by using endoprotease Lys-C and LC-MS/MS method. B. Deliverables • Provide the test results in Microsoft (MS) Word format, information shall include, but not be limited to, results of each test, significant findings, and implications • MS PowerPoint presentation summarizing the results • Computations in Excel format • Support data used to derive results in TIF or PDF format • Deliverables shall be delivered to the Technical Point of Contact (to be named upon contract award) via email Part III: Supporting Information A. Place of Performance Deliverables shall be provided to: U.S. Food and Drug Administration Center for Biologics Research and Evaluation 10903 New Hampshire Avenue Silver Spring, MD 20993 B. Period of Performance The Government will provide 16 samples to the contractor within 14- calendar days of contract award. The contractor shall perform all required tests and submit deliverables within 45-calendar days of receipt of samples. Period of performance: 59 calendar days from issuance of contract award. Part IV: Instructions to Prospective Respondents The offeror shall furnish sufficient information necessary for the Government to conclusively determine that the respondent is capable and otherwise qualified to perform the full range of services identified herein. At a minimum, responses shall include the following: Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, 8(a), SDB, WOSB, EDWOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address; Past performance information for the same or substantially services, description of work (should also include technical literature and specifications), 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; Descriptive literature, brochures, specifications, marketing material, etc. detailing the nature of the services the responding firm is regularly engaged in providing; If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this requirement; Although this is not a request for quote, informational pricing is encouraged; The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation. The Government is not responsible for locating or securing any information, not identified in the response. Interested parties must respond with capability statements, which are due in person, by postal mail or email to the point of contact listed below on or before July 31, 2015 by 10:00 AM (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, OO|OFBA|OAGS|DAP, Attn: Sondea Blair, 3900 NCTR Road, Bldg 50/Room 421, HFT‐320, Jefferson, AR 72079‐9502 or email sondea.blair@fda.hhs.gov. Reference Number 1144788 in all correspondence with the point of contact listed above. Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether this requirement should be set aside for small business, made available to full and open competition or procured through other than full and open acquisition procedures. 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 combined synopsis/solicitation (No. FDA-15-223-SOL-1151450) may be published via FedBizOpps. 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).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1151450/listing.html)
- Place of Performance
- Address: Deliverables shall be provided to:, U.S. Food and Drug Administration, Center for Biologics Research and Evaluation, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN03800293-W 20150718/150717000027-e8af475688de5671a417930bbfbc18a6 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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