SOLICITATION NOTICE
A -- Production of Polyclonal Antisera & Monoclonal Antibodies to Heat Stable Proteins
- Notice Date
- 5/24/2002
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Division of Construction and Agency Support Contracting, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA007012
- Response Due
- 6/10/2002
- Archive Date
- 6/25/2002
- Point of Contact
- Patricia Wright, Contract Specialist, Phone (301) 827-7163, Fax (301) 827-7103,
- E-Mail Address
-
pwright@oc.fda.gov
- Description
- The Food and Drug Administration intends to award a Purchase Order on a sole source basis to Covance Research Products, PO Box 7200, Denver, PA 17517. Covance Research Products provide the FDA services for the production of polyclonal antisera and monoclonal antibodies against heat stable antigens provided by the FDA. These antiseras and monoclonal antibodies will be used to test feed and feed ingredients for the presence or absence of prohibited materials. The results of these analyses will be used for research purposes and may also be used to aid FDA's enforcement of the feed ban. Within the first 90 days, the contractor will have initiated production of both polyclonal antisera and monoclonal antibody production. Concerning polyclonal antisera production, within the first 60 days, two goats will have been immunized with a combination of Freund's Complete Adjuvant and Freund's Incomplete Adjuvant a total of three times, with a minimum of one ELISA screening assay being conducted after the last of these four immunizations. Within the first 180 days, animals producing acceptable antisera will have been moved into a production schedule designed to yield larger amounts of antisera. Ideally, this process would use a procedure such as plasmapheresis, which is capable of yielding 800-1000 ml of plasma, as opposed to the typical yield of 200 ml of sera typically obtained when obtaining large volumes of blood from goats. This schedule of production will be maintained through the end of the contract. Within the first 90 days, the contractor will have immunized a minimum of 5 mice for production of monoclonal antibodies. The contractor will have also tested the plasma from these same mice so the scientists at CVM can select the most appropriate animal. Within the next 90 days, contractor will have used this animal to produce hybridomas. The contractor will also conduct an initial ELISA screen of all wells showing positive growth as well as a second round of ELISA screening following the subcloning process. Additional work may include, but is not limited to, cryopreservation of cells from all positive primary wells, cloning of all selected positive wells with ELISA testing, expansion and/or cryopreservation of primary clones as well as subclones. Once suitable hybridomas have been identified, contractor will begin in vitro production of the monoclonal antibody(ies) using either CL 1000 or hollow fiber bioreactor technologies. The FDA anticipates a one (1) year period of performance. An award will be made fifteen (15) days from date of this notice. This is not a request for quotes, however, sources may submit descriptive literature which full demonstrate their product meets the specification which shall be considered by the agency. This sole source procurement will be awarded as a simplified acquisition in accordance which FAR Subpart 13.5
- Record
- SN00082919-W 20020526/020524213123 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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