SPECIAL NOTICE
A -- Development of a Final Drug Product for a Mixture of Monoclonal Antibodies for type A Botulinum Neurotoxins
- Notice Date
- 1/24/2006
- Notice Type
- Special Notice
- 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
- NIH-NIAID-DMID-06-38
- Response Due
- 3/9/2006
- Archive Date
- 3/24/2006
- Description
- The Division of Microbiology and Infectious Disease (DMID), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS) intends to negotiate with XOMA LLC for a multiple-year contract under the Authority of 41 U.S.C. 253(c)(1), as set forth in FAR 6.302-1(b)(1)(i), Unique Capabilities. THIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. Inherent duplication of cost to the Government and unacceptable delays in completing the project make competition unfeasible for this requirement. The proposed contract will permit XOMA LLC to expand the studies and services required to develop and evaluate the monoclonal antibodies (mAbs) specific for botulinum neurotoxin serotypes A1 and A2. These mAbs are being manufactured under contract HHSN266200500004C as three separate bulk drug substances and are to be developed into a single combined and formulated final drug product to a stage that will allow for submission of an Investigational New Drug application to the Food and Drug Administration. XOMA LLC has an agreement with University of California in San Francisco that gives them access to the three promising mAbs. Also, XOMA LLC has used proprietary technology to develop the Master Cell Banks and the Master Working Cell Banks, analytical assays, a manufacturing process, and the bulk drug substances. XOMA LLC is the only known source that possesses the knowledge and materials required to perform the studies and services that are required under the proposed contract. In addition, XOMA LLC has established a close and productive relationship with the inventor of the mAbs, which is crucial to the success of the proposed contract. Interested parties may identify their ability and submit capability statements in response to this requirement and must submit the information on/before the closing date noted in this announcement. Organizations that submit capability statements in response to this announcement must demonstrate their ability to assume the work without unnecessary delay and duplication of cost and effort. See Numbered Note 22. No collect calls will be accepted.
- Place of Performance
- Address: U.S.
- Record
- SN00971919-W 20060126/060124211814 (fbodaily.com)
- Source
-
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