SOURCES SOUGHT
B -- Equine Ebola Antibody Production
- Notice Date
- 6/20/2016
- Notice Type
- Sources Sought
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA_16-223-SOL-1169554
- Archive Date
- 7/12/2016
- Point of Contact
- Howard Nesmith, Phone: 870-543-7459
- E-Mail Address
-
howard.nesmith@fda.hhs.gov
(howard.nesmith@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO TELEPHONE CALLS WILL BE ACCEPTED REQUESTING AN RFQ PACKAGE OR SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. IN ORDER TO PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT, IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE. The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) has issued this sources sought announcement on behalf of the Center for Biologics Evaluation and Research (CBER), who requires Equine Ebola Antibody Production. If your firm is considered a small business source under North American Industry Classification System (NAICS) 325414 - Biological Product (except Diagnostic) Manufacturing ; with a Small Business Size standards in number of employees 1,250, and believe your firm would be able to provide the FDA with the Equine Ebola Antibody Production as described below, please submit an email to howard.nesmith@fda.hhs.gov. The vendor shall include information about the company which demonstrates they can meet all of the minimum requirements. Background: Ebola virus is a filovirus that causes hemorrhagic fever with an average mortality rate of 50 % (WHO, at http://www.who.int/mediacentre/factsheets/fs103/en/). There are no licensed treatments or vaccines against Ebola to date although several candidates are under study. Passive immune therapy with human or animal-derived antibodies has been successful for prevention or treatment of viruses such as rabies, vaccinia, hepatitis A, hepatitis B, and Argentine hemorrhagic fever. Non-government organizations have begun to collect convalescent plasma from Ebola survivors in an effort to study antibody therapy. Standardized tests to measure Ebola antibody activity are not well developed, in part due to lack of standard anti-Ebola antibody preparations. A well characterized high-titer neutralizing antibody preparation could be used to assure that antibody tests for diagnosis and surveillance for Ebola infections are valid and can be compared to each other. Development of standards from human convalescent serum from Ebola survivors is not feasible because a steady large volume of material with consistent titers is not available. Antibody levels vary from donor-to-donor and time-to-time in the same donor, Ebola plasma is difficult to ship due to questions of residual infectivity and international requirements, and may not be conducive to routine Biosafety Level Criteria Secondary Barriers (BSL-2) laboratory use. Furthermore, convalescent plasma does not always contain high neutralizing antibodies. In contrast, equine hyperimmune vaccine protocols to stimulate specific antibody production are well-established in general, and large quantities of immune plasma may be obtained without compromising health of the animals. The goal of the FDA is to obtain and evaluate equine Ebola immune plasma as a safe, consistent, BSL-2 reagent candidate standard. The FDA will characterize the immune plasma using neutralization, antibody-dependent cytotoxicity, and complement-mediated cytotoxicity assays, to comprehensively define the antibody function. This will be shared with other laboratories for testing and use as a reagent to facilitate development of test methods, and as a positive control/comparator for Ebola antibody therapies in development. Statement of Need: CBER requires services to develop Equine Ebola Antibody for a consistent, easily available standard to measure functional activities of human serum anti-Ebola antibodies is for assessment of candidate passive immune therapies, vaccine potency, and to better understand how effective anti-Ebola antibody function. A widely available standard should facilitate development of vaccines, tests, and treatments for Ebola virus. Technical Requirements: - The Contractor shall have a properly resourced facility for equine vaccination, blood collection, and plasmapheresis. - The Contractor shall assure that prior to vaccination, horse(s) are in good health. - The Contractor shall vaccinate horses with Ebola glycoprotein with or without adjuvant, intradermally or subcutaneously up to 10 times on a 1-3 week basis. - The Contractor shall have or have access to a BSL-2 laboratory for processing equine serum and plasma - The Contractor shall collect and process blood samples a) 14 days after the prior vaccination and b) on the day of booster vaccination (just prior to vaccination). - The Contractor shall process blood into serum, and frozen at -20o C for shipment to FDA. - The Contractor shall provide, along with samples, horse identification number, time of last immunization, amount of immunogen and amount/type of adjuvant used, immunization number, and time of collection. - The Contractor shall supply 50 mL of serum and one plasmapheresis unit from a horse that has not received Ebola glycoprotein vaccination, for FDA use as a laboratory control. - The Contractor shall plasmapherese one horse with high antibody titers, selected by FDA, to collect not more than 20 mL/kg of plasma, which will be frozen at -20o C and shipped to FDA. - The Contractor shall ship frozen serum and plasma to arrive within 24-48 hours at FDA's Silver Spring, Maryland facility. FOB Destination: U.S. Food and Drug Administration Center for Biologics Evaluation and Research 10903 New Hampshire Avenue Silver Spring, MD 20993 Responses to this sources sought shall unequivocally demonstrate that the respondent is regularly engaged in Equine Ebola Antibody Production, shall demonstrate prior experience in equine husbandry, equine hyperimmune vaccination protocols using proteins (with or without adjuvants), serum and plasma collection for production of Ebola antibodies, and shall have or have access to a BSL-2 laboratory for processing of equine serum and plasma. Though the target audience is small business or small businesses capable of providing service from another small business, all interested parties 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, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. Provide this same information again if responding to provide a service offered by another firm. - Past Performance information shall include date of services, description, dollar value, client name, client address, client 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 company (to include DUNS number and size status) if not the respondent. - Descriptive literature, brochures, marketing material, etc. detailing the nature of 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 potential requirement are also requested. If a large business, provide if subcontracting opportunities exist for small business concerns. The Government is not responsible for locating or securing any information, not identified in the response. Interested Contractors must respond with capability statements in person, by e-mail, fax, mail or other delivery method before 1:00 pm (Central Standard Time - Local Prevailing Time in Jefferson, Arkansas) on June 27, 2016 to howard.nesmith@fda.hhs.gov, Fax (870) 543-7990, or mail to the U. S. Food and Drug Administration, OO/OFBA/OAGS/DAP, Attention of Howard Nesmith, 3900 NCTR Road, Building 50, Room 424, Jefferson, AR 72079-9502 and Reference: FDA_16-223-SOL-1169554. 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 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). Additional Notes: If the stated requirements appear restrictive, please submit comments detailing the concern. Though this is not a request for quote, informational pricing for the service would be helpful.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA_16-223-SOL-1169554/listing.html)
- Place of Performance
- Address: U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN04155529-W 20160622/160620234613-261335e2ebb88c9c51a497f74c057784 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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