SOURCES SOUGHT
A -- Evaluation and Qualification of the MIMIC System
- Notice Date
- 4/17/2013
- 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, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- 1115909
- Archive Date
- 5/14/2013
- Point of Contact
- Marcia O Park, Phone: (870) 543-7405
- E-Mail Address
-
marcia.park@fda.hhs.gov
(marcia.park@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Sources Sought Notice to determine the availability and capability of Small Businesses capable of Evaluation and Qualification of the MIMIC System and functional immunoassays for Determining the Immunogenicity of Vaccines and Screening Synthetic Peptides as Vaccine Candidates. 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 services described 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. The applicable North American Industry Classification System (NAICS) code is 541711, Research and Development in Biotechnology and the size standard is 500 employees. The U.S. Food and Drug Administration (FDA) is seeking to identify sources that can provide the services as described in this notice. Background Preclinical evaluation of immunogenicity of live and inactivated vaccines is conducted in a variety of animal models. They have an obvious limitation determined by species-specific differences in immune response to different antigens. Therefore the ultimate assessment of immunogenicity is possible only in human systems. There are a number of in vitro models that study antigenic structure of vaccines rather than its ability to induce specific protective antibodies. It would be highly desirable to assess and qualify an in vitro biomimetic system that would mimic immune responses that occur in humans after administration of protective antigens. Screening for synthetic immunogenic peptides that could potentially be used as vaccines is also done in animal models that suffer from the same limitations. The need to use animals also limits the number of peptides that may be screened. Use of a high-throughput system would significantly increase chances of finding the right immunogenic peptides. VaxDesign developed a system that is called MIMIC (Modular Immune In vitro Construct). The MIMIC system is comprised of isolated primary human immune cells integrated into engineered tissue constructs that are functionally equivalent to the physiological environment of the human immune system. By accurately representing the cellular synergy and communication kinetics that are critical for the induction of adaptive immunity in vivo, VaxDesign has shown the potential of the MIMIC model to support the sensitization of primary human B and T cell responses in an in vitro setting. The study currently being conducted by the Food and Drug Administration's Center for Biologic Evaluation and Research, Office of Biostatistics and Epidemiology (FDA/CBER/OBE) includes 50 donors immunized with Inactivated Polio Vaccine (IPV) (commercial vaccine). Both pre-vaccination and post-vaccination apheresis products have been collected. Various immunoassays were performed based on in vivo/serum, ex vivo, and in vitro/MIMIC assays. Immune response data with regard to serum antibody against polio serotypes 1, 2, and 3, T cell response measured by the enzyme-linked immuno sorbent spot (ELISPOT) and multiparameter flow cytometry, B cell response measured by polio serotype-specific antibody titers, as well as enzyme-linked immuno sorbent assay (ELISA) neutralization titers will be available for analysis. Project Objectives The goal of this Research Project is to Evaluate and Qualify the MIMIC System and functional immunoassays for Determining the Immunogenicity of Vaccines and Screening Synthetic Peptides as Vaccine Candidates. In addition to helping characterize the immunogenic properties of natural and synthetic peptides, the prospective contractor shall help determine whether the automated MIMIC system is a suitable tool for the high-throughput screening of large libraries of synthetic peptides for potential in vivo immunological activity. The use of fully synthetic peptides to induce protective immunity would have tremendous safety and cost reduction benefits. A major obstacle to realizing synthetic peptide vaccines has been the difficulty in screening synthetic peptides for immunogenic activity. This goal is consistent with FDA's Critical Path goals of bringing new technologies to the development, characterization and validation of the next generation of biological products. Though the target audience for this sources sought are small businesses, all interested parties, regardless of size status are encouraged to respond. Description of Work/Tasks The prospective contractor shall provide statistical data analysis and reporting for this project to include:. Association/correlation between in vitro immune results obtained in culture and the in vivo virus-specific responses. Qualification of novel functional assays. Exploration of the impact of baseline characteristics of the donors on the validity of the in vitro results. Development of analysis modules for use in future research of the validity of the MIMIC system for other vaccines Period of Performance is 6 months; minimum of two meetings with the government staff at 1401 Rockville Pike, Rockville, MD 20852 shall be required. Parties submitting capability statements shall be advised that generic capability statements are not sufficient for effective for evaluation of respondents' capacity and capability of providing the required services. Respondents should limit their capability statements to no more than ten (10) pages in length, excluding standard brochures, technical literature and any other information that demonstrates the capabilities of the contractor to meet the Government's requirement. Provide two contact names, email and phone numbers for similar projects that may be contacted by the Government. Potential contractors must indicate business size, proof of any set-aside certification and company's DUNS number and provide a contact name, the mailing address, phone number, email address of point of contact and reference #1115909. Identification of any applicable GSA contract number, schedule number, SIN number that may be applicable to this potential requirement are also requested. Interested parties must respond with capability statements in person on or before April 29, 2013 by 1:00 PM (Central Time) Jefferson, Arkansas, at the Food and Drug Administration, Office of Acquisitions and Grants Services, Field Operations Branch, Attn: Marcia Park, 3900 NCTR Road, HFT-322, Jefferson, AR 72079-9502; Faxed to 870/543-7990 or emailed to Marcia.park@fda.hhs.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/1115909/listing.html)
- Place of Performance
- Address: Contractor's facility with meetings at Government facility 1401 Rockville Pike, Rockville, MD 20852, United States
- Zip Code: 20852
- Zip Code: 20852
- Record
- SN03039388-W 20130419/130417235125-6a6f244111268e98d6fdf0d8e5249654 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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