SOURCES SOUGHT
A -- .Request for Milligram Amounts of Purified Quality-Controlled Botulinum Toxins (Complex and Holotoxins) for Biodefense Research
- Notice Date
- 7/29/2005
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Contract Management Program 6700 B Rockledge Room 3214 MSC7612, Bethesda, MD, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- Reference-Number-30067ATCC
- Response Due
- 8/22/2005
- Archive Date
- 9/6/2005
- Description
- THIS REQUEST IS BEING POSTED IN THE FEDBIZOPPS FOR AMERICAN TYPE CULTURE COLLECTION (ATCC) BY THE NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID). THIS IS NOT A REQUEST FOR PROPOSAL (RFP). ALL RESPONSES SHOULD BE DIRECTED TO THE ATCC CONTACT. This is a sources sought notice from ATCC to conduct a market survey to determine the availability and capability of offerors to provide for the following requirements wholly or partly as outlined below. As part of the work being provided by ATCC to NIAID, we at ATCC have a requirement for 10 to 100 milligram amounts of purified quality controlled botulinum toxins (BoNT) (toxin complex and holotoxins) for biodefense studies: (a) BoNT A; (b) BoNT B; (c) BoNT E. All seven bacterial strains required for this project will be provided by ATCC to the offeror. These purified toxins may be used as primary standards on which future basic research and product development pathways will rely. There is the potential need for these proteins to be produced and tested in accord with current Good Manufacturing Practices (cGMP, 21 CFR 210 and 211) and Good Laboratory Practices (GLP, 21 CFR 58) regulations. There is also the potential need for these proteins to be produced as research grade reagents. Potential Sources should: (1) have knowledge and experience in the production and purification of various complex toxins and holotoxins of BoNT subtypes; (2) provide evidence that they have or can establish adequate facilities and procedures for the production, purification and packaging of BoNT A, B and E; (3) develop and utilize appropriate analytical methods to conduct quality control testing for identity, purity, quantity, stability and biological activity using recognized mouse bioassays; (4) have process development knowledge and experience in toxin formulation and packaging to support highly efficient recovery from the container, stable shelf life, and safe transportation and handling of toxins produced; and (5) demonstrate compliance with all applicable federal biosafety and biosecurity regulations including, CDC and USDA Select Agent Registration ( 42 CFR 72 and 73; 7 CFR 331 and 9 CFR 121). All bacterial strains required for this project will be provided by ATCC to the offeror. ATCC is not committed to award a subcontract or purchase agreement pursuant to this announcement. Interested offerors may furnish capability information for reagent grade and/or GMP grade preparations of individual toxins or for all toxins. Capability statements addressing the above items should not exceed 10 pages and should be submitted by COB August 22, 2005, to Dr. James Anthony by email (janthony@atcc.org) or FAX 703-365-2730. No telephone inquiries will be accepted. Do not attempt to contact anyone at NIAID regarding this request. You must correspond with ATCC staff only.
- Record
- SN00857815-W 20050731/050729211906 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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