SOURCES SOUGHT
65 -- Monoclonal Antibody Production
- Notice Date
- 7/23/2015
- 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 - Jefferson, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- FDA1151574
- Archive Date
- 8/14/2015
- 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 Office of Regulatory Affairs (ORA) Winchester Engineering & Analytical Center (WEAC) requirement for Monoclonal Antibody Production in Mice. This is a Sources Sought Notice to determine the availability and capability of small businesses that can provide Monoclonal Antibody Production in Mice as set forth herein. 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 325414 Biological Product (except Diagnostic) Manufacturing, Small Business Size 500 employees. Statement of Work (SOW) WEAC requires monoclonal antibody production in mice to develop protocols to provide monoclonal antibodies required to assemble prototype rapid point-of care multiplexed diagnostic devices, provide purified monoclonal antibodies that are needed for the capture and detection of antigens/disease markers for use on multiplexed lateral flow devices, provide purified antibodies which will be used to achieve maximal diagnostic detection sensitivity and specificity by optimizing antibody/viral protein coupling to gold and fluorescent nanoparticles, and design and assemble a matrix-coded Multiplexed diagnostic device(s); to evaluate the sensitivity and specificity of detecting priority pathogens; to develop a mobile phone interface to display results. The lack of available point-of care diagnostics for infectious diseases represents vulnerability in biodefense preparedness as well as a gap in serving the public health needs. Technical Requirement At a minimum, the Contractor shall provide a quantity of 4 Monoclonal Antibody Immunizations/Productions to include the following: 1. Monoclonal Antibody production in Mice 2. Shall include Peptide Synthesis and conjugation 3. Shall include Immunization 4. Shall include Fusion and Subclone phase 5. Shall include initial screening of 1000 clones (Hybridomas) 6. Shall include initial screening data (ELISA) of Top 50 clones. 50/1ml vials 7. Shall include Subclone phase in which 3 clones selected from previous step (#6) are subcloned each onto 2 plates each. 8. Shall include approximately 10-15 top clones from 3 subclones from previous step (#7) for screening. 9. Shall include one Roller Bottle Production and Purification up to 1L (one Cell line) from previous step (#8). 10. Shall include 10-20 vials of purified antibody (3-15mg/ml) from roller bottle purification. 11. Shall have total animals = 5 Balb/c mice (per antibody) 12. Shall have daily cage side observation morbidity and mortality checks The Government will provide the Contractor with the protein within 2 weeks after contract award. Deliverables: The Contractor shall provide the Government with a minimum of 3 cell lines that will produce antibody. Period of Performance: Twelve (12) months from receipt of protein from the Government. Place of Performance Winchester Engineering & Analytical Center 109 Holton Street Winchester, MA 01890 The respondent to this source sough shall furnish sufficient technical information necessary for the Government to conclusively determine its capability to provide the services meeting the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of providing the services, all interested parties may respond. 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; Sufficient descriptive literature that unequivocally demonstrates that offered services meet or exceed above specifications. All descriptive material necessary for the government to determine whether the services 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 July 30, 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 FDA1151574. 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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