SOURCES SOUGHT
A -- Final Drug Product Scale-Up, Manufacture, Assay and Stability Studies
- Notice Date
- 5/6/2010
- Notice Type
- Sources Sought
- Contracting Office
- US Army Space and Missile Defense Command, Deputy Commander, ATTN SMDC-CM-AP, P.O. Box 1500, Huntsville, AL 35807-3801
- ZIP Code
- 35807-3801
- Solicitation Number
- DVC0142-PLAG-10
- Response Due
- 5/14/2010
- Archive Date
- 7/13/2010
- Point of Contact
- Leo Fratis, (301)619-7421
- E-Mail Address
-
US Army Space and Missile Defense Command, Deputy Commander
(Leo.Fratis@amedd.army.mil)
- Small Business Set-Aside
- N/A
- Description
- DynPort Vaccine Company LLC, a CSC company (DVC) is the prime systems contractor for the U.S. Department of Defense Joint Vaccine Acquisition Program (JVAP) and is responsible for the advanced development and licensure with the Food and Drug Administration (FDA) of vaccines and other biological products designed to protect against a variety of biological agents. As part of this program, a recombinant vaccine for protection against pneumonic plague is undergoing advanced development by DVC. The antigenic component of this vaccine is a single protein produced from a fusion of the Yersinia pestis genes for the F1 capsular protein and the V virulence protein. The product is currently being investigated in the U.S. under a DVC sponsored IND. DVC is seeking the technical services for scale-up and validation of a process to formulate, fill, inspect, label and test the rF1V final drug product in at least 300,000 single-dose vials per lot. Additionally, DVC is seeking the technical services for the technology transfer and validation of product-specific assays necessary for release and stability testing of the product. 1.0OBJECTIVES 1.1Technology Transfer and Validation of rF1V analytical methods 1.1.1 Product-Specific Assays Required will include at minimum LDS-PAGE, Western Blot, an HPLC method and a CE method. 1.2Development and Validation of a Scaled-Up Fill Finish Process Sufficient to Manufacture At Least 300,000 Vials Per Lot 1.2.1 Assume a 0.8 mL fill in a 3 mL glass vial, and the product will require active mixing as it is adjuvanted and will settle out if not maintained in a well-mixed state. 1.3Manufacture Four Engineering Lots and Three Consistency Lots for Use in Non-Clinical and Clinical Studies 1.3.1 At least one Engineering Lot and all three Consistency Lots will be manufactured under GMP conditions. 1.3.2 Media Qualification prior to GMP lots will be required. 1.4 Release Test All Seven Full Scale rF1V Final Drug Product Lots 1.5 Conduct Stability Studies on One Engineering Lot and All Three Consistency Lots. 1.5.1 The Engineering Lot will require 13 stability time points over 5 years. 1.5.2 The Consistency Lots will require a total of 49 stability time points over 5 years. Please respond to this Sources Sought with your capabilities/past performance and interest to Jo Ann Brown, Principal Subcontract Administrator, DVC LLC, a CSC company at jbrown253@csc.com Please only contact the person noted above and not the USASMDC office listed in this announcement.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/SMDC/DASG60/DVC0142-PLAG-10/listing.html)
- Place of Performance
- Address: US Army Space and Missile Defense Command, Deputy Commander ATTN SMDC-CM-AP, P.O. Box 1500 Huntsville AL
- Zip Code: 35807-3801
- Zip Code: 35807-3801
- Record
- SN02142986-W 20100508/100506235558-7351c232235f17c9a4de5896995a18f2 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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