SOLICITATION NOTICE
B -- Manufacture of Master Virus Bank
- Notice Date
- 11/29/2004
- Notice Type
- Solicitation Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy & Infectious Diseases/AMOB, 10401 Fernwood Drive, Suite 2NE70, MSC 4811, Bethesda, MD, 20817
- ZIP Code
- 20817
- Solicitation Number
- Reference-Number-N01-AO-32757
- Response Due
- 1/12/2004
- Description
- The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) has a sole source requirement for the manufacture of a master virus bank of non-replication competent adenoviral vectors containing Ebola gene inserts using a suitable packaging cell line. This master virus bank will be used in the future production of clinical grade adenoviral vector lots. The current contract, N01-AO-32757, with Crucell Holland BV, will be modified to add this requirement. Crucell has been identified as the only responsible source for this procurement for two reasons: 1) all of the remaining MVBs and clinical trial materials for the Ebola vaccine candidate have been manufactured by Crucell using a uniform and approved process. It is imperative that the identical process is used for manufacture of this MVB in order to ensure product consistency and regulatory approval, and 2) Crucell is currently the only source of a packaging cell line, PER.C6(TM) , which does not produce replication-competent adenovirus (RCA). Any questions or capability statements should be forwarded to Terrie Nestor, tnestor@niaid.nih.gov, by 2:00pm on January 12, 2005. See Note 22.
- Place of Performance
- Address: Leiden, Netherlands
- Record
- SN00713862-W 20041201/041129211634 (fbodaily.com)
- Source
-
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