SOURCES SOUGHT
A -- Identify manufacturers that have Good Manufacturing Practices (cGMP) capability to produce purified drug substance (PDS) at intermediate and commercial scale.
- Notice Date
- 6/29/2007
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- 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
- W9113M-S-0008
- Response Due
- 7/15/2007
- Archive Date
- 9/13/2007
- Small Business Set-Aside
- N/A
- Description
- This is a sources sought notice. The purpose of this announcement is to identify manufacturers that have current Good Manufacturing Practices (cGMP) capability to produce purified drug substance (PDS) at intermediate and commercial scale. The antig enic 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 (rF1V). The Department of Defense (DoD), through the Chemical Biological Medical Systems (CBMS) Joint Vaccine Acquisition Program (JVAP) is seeking contractors capable of completing the process definition, technical transfer, and cGMP manufacture of PDS at intermediate and commercial sale. The capabilities are as follows: 1) Confirm the process def inition; 2) Achieve successful technical transfer and cGMP manufacture of purified drug substance (PDS) using an intermediate production scale (100L) process. This includes microbial fermentation and purification of PDS at the 100L scale, technical transf er and validation of product specific assays, PDS testing, and cGMP lot release; 3) Scale-up and optimize a cGMP commercial scale at a minimum of 1000L. Execution of process characterization and process validation studies is required. In addition, the ro uting cGMP commercial manufacture and lot release of rF1V PDS is required to supply product for clinical and nonclinical studies and stockpile of final licensed product. This is not a request for competitive proposals, however, parties interested in respo nding must furnish, in writing , a 1-2 page synopsis of their capabilities and related past performance. Any information received in response to this sources sought notice that is marked proprietary will be handled accordingly. This information may be su bmitted via mail, email, or fax. All responses are to be submitted by not later 15 July 2007 by 3:00PM EST in order to be accepted for review. All paperwork must be sent to U.S. Army Space and Missile Defense Command, ATTN: Lynn Selfridge, 64 Thomas Joh nson Drive, Frederick MD 21702, or Fax 301-619-5069, or email lynn.selfridge@det.amedd.army.mil. This notice should not be construed as a request for proposals or an obligation on the part of the U.S. Government and responses cannot be accepted by the Gov ernment to form a binding contract. Any work effort that may result from this sources sought notice will be conducted through a prime systems contractor and the Government.
- 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
- Country: US
- Zip Code: 35807-3801
- Record
- SN01331810-W 20070701/070629231520 (fbodaily.com)
- Source
-
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