SOLICITATION NOTICE
68 -- Fetal Bovine Sera
- Notice Date
- 6/28/2007
- Notice Type
- Solicitation Notice
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- Reference-Number-FDA1031383
- Response Due
- 7/13/2007
- Archive Date
- 7/28/2007
- Description
- The Food and Drug Administration intends to award a purchase order on a sole source non-competitive basis to HyClone, 925 West 1800 South, Logan, Utah 84321. The FDA will purchase fetal bovine sera from HyClone. The grade of fetal bovine sera designated as ?defined,? manufactured only by the HyClone subdivision of Thermo Fisher Scientific, is critical for success of many of FDA?s research efforts. HyClone ?defined? serum is strictly necessary to maintain continuity with ongoing experiments and assays being developed by FDA scientists. This source is necessary because of the large volume of work with primary, non-transformed mouse lymphocytes, which do not function and die without sera of this quality in the growth media. This supply of sera was originally chosen because it is the only source on the market in the U.S. to meet the following specifications, all of which are essential for our research purposes: endotoxin (per limulus amoebocyte lysate - gel clot), <10 EU/mL; hemoglobin (spectophotometric), <10 mg/dl; complete sterility testing per current USP and EP; filtration through serial 40 nm (0.04 ?m) pore-size rated filters, resulting in over 8 logs of viral load reduction, as demonstrated by complete virus testing (per 9 CFR 113.53) with all major bovine viral adventitious agents (bluetongue, bovine adenovirus, bovine parvovirus, bovine respiratory syncytial virus, bovine viral diarrhea virus, rabies, reovirus, cytopathogenic agents, and hemadsorbing agents) determined to be negative; and exhaustive biochemical characterization (including assessment of progesterone, isulin, cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol, triglycerides, gamma globulin, phospholipids, alkaline phosphatase, lactate dehydrogenase, glutamic pyruvic transaminase [SGPT], glutamic oxaloacetic transaminase [SGOT], thiamine [B1], riboflavin [B2], pyridoxine [B6], nicotinic acid [niacin], vitamin H [biotin], vitamin A [retinol], carotene, total vitamin E [tocopherol], cyanocobalamine [B12], pteroylglutamic acid [folate], vitamin C, 1,25 dihydroxy vitamin D, pH, total protein, albumin, blood urea nitrogen, creatinine, total bilirubin, inorganic phosphorus, osmolality, iron, selenium, IgG, sodium, potassium, calcium, chloride, magnesium, glucose, copper, total iron binding capacity [TIBC], and percent saturation). THIS IS NOT A REQUEST FOR QUOTES. However, sources may submit descriptive literature, fully documenting their capabilities, which will be considered by the agency. A determination to compete this procurement based on response(s) to this notice is solely within the discretion of the Government. The FDA intends to make an award immediately after the response date of this notice. The award will be made in accordance with FAR Part 13, Simplified Acquisition Procedures.
- Record
- SN01330168-W 20070630/070628220700 (fbodaily.com)
- Source
-
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