SOURCES SOUGHT
B -- Aptamer-Based Bacterial Filter Development
- Notice Date
- 4/17/2015
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- 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
- 1147130
- Archive Date
- 5/12/2015
- Point of Contact
- Crystal G. McCoskey, Phone: 8705437267
- E-Mail Address
-
crystal.mccoskey@fda.hhs.gov
(crystal.mccoskey@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 to provide services for development of an aptamer-based bacterial filter suitable for decontaminating platelet concentrates. The associated North American Industry Classification System (NAICS) Code is‐ 541990 All Other Professional, Scientific and Technical Services; Small Business Size Standard is $15.0 million. Section I: Requirements Part I: Background In the United States, at least 100 reported cases of mortality or severe morbidity are attributed to bacterial contamination of transfused Platelet Concentrates (PC) each year and more cases are certainly underreported. Bacterial detection technologies are currently used to reduce the risk of transfusion-transmitted sepsis. A limitation of these technologies is that units contaminated with small numbers of bacteria are often missed; such units can cause sepsis in immunocompromised recipients. Thus, current bacterial detection is not sufficient to ensure maximum safety of PC, and alternative approaches are desirable. Based on this, the U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) has a requirement for development of a filter that removes bacteria from a PC unit, thereby rendering the unit safer to transfuse. The required device shall be a membrane-based filter containing bacteria-specific affinity ligands. The main advantage of bacterial filters, would be to remove bacteria even when present in PC in undetectable numbers. The goal of this project is to establish proof of concept for such a device. This device will improve the safety of platelet transfusions and enhance public health. Early work conducted by FDA personnel using peptide ligands showed that some peptides bound to bacteria with strong affinity in saline suspension but under physiological conditions in which bacteria were mixed with platelets the peptides bound poorly. These results suggested that higher affinity between the ligand and the bacteria cell was needed. After a literature search, the FDA concluded DNA aptamers might be better ligands. DNA aptamers are oligonucleotide structures that, in theory, should offer more selective and higher-affinity binding to bacterial cells than peptides. Aptamers that bind bacteria are selected from randomly generated aptamer libraries. Based on the aforementioned, CBER has a need for screening of aptamer libraries for binders of three bacteria: S. epidermidis, S. aureus, and E. coli. The screening selection is expected to be conducted in the presence of platelet concentrates. During the screening process, steps have to be introduced to remove non-specific aptamers and aptamers that bind plasma proteins or platelets. The process of selection must be one-step and take no longer than one (1) week for the three bacteria due to the time sensitivity and constraints of the research project. Once the FDA receives the aptamer pools from the Contractor, the cloning and sequencing will be conducted. Afterwards the sequencing information will be provided to the Contractor for ranking of the aptamers based on predicted thermostability. It is expected the Contractor will be able to identify the aptamer sequence of the two (2) best candidates per each bacteria based on the sequencing provided. Part II: Requirements A. Scope The contract shall conduct aptamer selection against three (3) bacteria S. epidermidis, S. aureus, and E. coli. using a selection method that involves only a one-step protocol. The contractor shall provide the three bacterial strains. The aptamer pools shall have been screened in the presence of platelets, and those aptamers that bind plasma proteins and platelets shall be removed. The contractor shall send the aptamer pools to FDA no later than three (3) months after the date of award. Each pool shall contain at least two (2) and up to 200 aptamer sequences. The FDA will provide the Contractor with the sequencing of all or some aptamers in the pools within six (6) months of receipt of the aptamer pools. Once the sequencing is provided, the Contractor shall conduct thermodynamic stability testing to identify consensus sequences among those aptamers identified in the pools. The contractor shall rank aptamers based on an algorithm for predicted thermostability. Within three (3) months after receipt of the sequencing from the FDA, the Contractor shall run the algorithm and provide the sequences of the top two (2) aptamers with the highest affinity to each of the three (3) bacteria strains. B. Deliverables i) Contractor shall deliver at least 0.5 ml each of three (3) pools of aptamers within three (3) months after contract award with each pool composed by two to maximum 200 aptamers that have been selected by screening against plasma proteins and platelets for binding S. epidermidis, S. aureus, and E. coli. ii) Contractor shall provide a ranking of the aptamers based on predicted thermostability to FDA and provide the best two (2) sequences for each bacterial strain tested within three (3) months of the receipt of the sequencing from the FDA. Additionally, the Contractor shall provide rationale for the selection of the two (2) best aptamers. iii) Contract shall provide monthly progress reports during development of the aptamers and the ranking processes. C. Delivery 10903 New Hampshire Avenue Building 52/72, room 4336 Silver Spring, MD 20993 D. Period of performance All three (3) aptamer pools shall be provided to the FDA within three (3) months of contract award. The FDA will provide the sequencing within six (6) months of receipt of the three (3) aptamers. Ranking of aptamers based on predicted aptamers' thermostability and the best two (2) sequences for each bacteria strain tested shall be provided three (3) months after receipt of aptamers' sequencing from the FDA. Total period of performance shall be one (1) calendar year from date of award. Section II: Instructions to Prospective Respondents Responses to this sources sought shall unequivocally demonstrate that respondent has the required equipment and personnel to perform the services. Though the target audience is small businesses capable of performing the services, any interested party may respond. 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; • Information on the equipment, personnel and methods to be used to develop the aptamers; • Three (3) years of past performance information for the service of same or substantially similar items, to include date of services, description (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, and client point of contact email address; • 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 April 27, 2014 by 1:00 PM (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, OC/OA/OAGS, Attn: Crystal G. McCoskey, 3900 NCTR Road, Bldg 50/Room 426, HFT‐320, Jefferson, AR 72079‐9502 or email crystal.mccoskey@fda.hhs.gov. Reference 1147130 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. 1147130) 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).
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