MODIFICATION
A -- Identify manufacturers that have Good Manufacturing Practices (cGMP) capability to produce purified drug substance (PDS) at intermediate and commercial scale.
- Notice Date
- 7/3/2007
- Notice Type
- Modification
- 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
- Point of Contact
- Susan Dell, 301-619-2383
- E-Mail Address
-
Email your questions to US Army Space and Missile Defense Command, Deputy Commander
(susan.dell@det.amedd.army.mil)
- 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 scale. The capabilities required are listed below: 1. Confirm the process definition. 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 transfer and va lidation of product specific assays, PDS testing, and cGMP lot release. 3. Scale-up and optimize a cGMP commercial process at a minimum of 1000L scale. Execution of process characterization and process validation studies is required. In addition, the routine cGMP commercial manufacture and lot release of rF1V PDS as 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 responding must furnish, in writing, a 1-2 page synopsis of their capabilities, earliest capacity for cGMP manufacturing at the 100L scale, and related past performance. Any i nformation received in response to this sources sought notice that is marked proprietary will be handled accordingly. This information may be submitted via mail, email, or fax. All responses are to be submitted by not later than 15 July 2007 by 3:00PM ES T 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 Johnson Drive, Frederick MD 21702, or Fax 301-619-5069, or email to 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 Government to form a binding contract. Any work effort that may result from this sources sought notice w ill be conducted through a prime systems contractor and not 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
- SN01334200-W 20070705/070703221608 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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