SOURCES SOUGHT
A -- Request for Gram Amounts of Purified Quality Controlled Recombinant Anthrax Protiens for Vaccine Studies
- Notice Date
- 8/16/2002
- Notice Type
- Sources Sought
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Contract Management Branch 6700-B Rockledge Drive, MSC 7612 Room 2230, Bethesda, MD, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- Reference-Number-85332McKesson
- Response Due
- 9/9/2002
- Point of Contact
- Barbara Shadrick, Senior%2BContracting%2BOfficer, Phone 301-000-0000, Fax 301-000-0000, - Barbara Shadrick, Senior%2BContracting%2BOfficer, Phone 301-000-0000, Fax 301-000-0000,
- E-Mail Address
-
martha.matocha@mckessonbio.com, martha.matocha@mckessonbio.com
- Description
- THIS REQUEST IS BEING POSTED IN THE FEDBIZOPPS FOR MCKESSON BIOSERVICES BY THE NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID). THIS IS NOT A REQUEST FOR PROPOSAL (RFP). This is a sources sought notice from McKesson BioServices 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 a part of the work being provided by McKesson BioServices to NIAID, we at McKesson have a requirement for the following gram amounts of purified quality controlled recombinant anthrax proteins for vaccine studies: (a) Protective antigen (PA), (b) Lethal factor (LF), and (c) Edema factor (EF). These reagent grade proteins should be >95% purity. There is also a potential need for these proteins to be produced in accord with Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP) for regulatory compliance studies. Potential Sources should have (1) knowledge and experience in the production and purification of recombinant proteins; (2) have or provide evidence that they can establish adequate facilities for the production, purification and packaging of these proteins; (3) develop and utilize appropriate analytical methods to conduct quality control testing for identity and purity, content, molecular weight variation, sterility, pyrogenicity, endotoxin content, biological activity using macrophage cytotoxicity assay, stability to freeze-thaw and stability at 37 degrees C; (4) offerors producing GLP/GMP grade PA, LF or EF must produce, process and package in full compliance with current 21 CFR Parts 58 and 211 Regulations; and (5) compliance with all applicable Government biosafety and security regulations. McKesson BioServices is not committed to award a subcontract pursuant to this announcement. Interested offerors may furnish capability information for reagent grade and/or for GLP/GMP grade preparations of individual proteins or all three proteins. Capability statements addressing the above items should not exceed 10 pages and should be submitted by COB September 9, 2002, to Dr. Martha Matocha by email (martha.matocha@mckessonbio.com) or FAX (301-340-9245). No telephone inquires will be accepted. Do not attempt to contact anyone at NIAID. You must correspond with McKesson staff only.
- Record
- SN00142517-W 20020818/020816213249 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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