PRESOL | A | Develop and qualify processes and protocols for high quality, high yield manufacture of pharmaceutical entities in accordance with cGMP and GLP-compiant studies.

FBO DAILY ISSUE OF APRIL 04, 2004 FBO #0860
SOLICITATION NOTICE

A -- Develop and qualify processes and protocols for high quality, high yield manufacture of pharmaceutical entities in accordance with cGMP and GLP-compiant studies.

Notice Date: 4/2/2004
Notice Type: Solicitation Notice
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-04-R-0009
Response Due: 5/27/2004
Archive Date: 7/26/2004
Point of Contact: Claudia.Addison, (301) 619-8442
E-Mail Address: Email your questions to US Army Space and Missile Defense Command, Deputy Commander
(claudia.addison@det.amedd.army.mil)
Small Business Set-Aside: N/A
Description: The US Army, Space and Strategic Defense Command, Chemical Biological Medical Systems intends to solicit and award a task order contract planned for a period of five to seven years. The requirements consist of developing and qualifying processes and protocols for high quality, high yield manufacture of pharmaceutical entities in accordance with current Good Manufacturing Practices (cGMP) regulations and guidelines and providing cGMP-compliant pharmaceutical materials for use in human clinical studies and in Good Laboratory Practices (GLP)-compliant non-clinical (animal) studies. The products to be made first are oximes (1 to 3) which have demonstrated effectiveness in the treatment of injuries induced by chemical warfare agents in animal models. Pro cess development and manufacturing efforts would be directed at ensuring the availability of required starting materials and the improvement of synthesis/manufacturing processes to achieve consistent high quality compounds and high yields. The pharmaceuti cal compounds would be manufactured in kilogram quantities in accordance with cGMP regulations and guidelines. Follow-on large-scale process validation and manufacturing may also be required. Future compounds may include candidate drugs for the treatment of vesicant agent injuries. No paper copies of the solicitation will be made available. An RFP is anticipated to be available 26 Apr 04. Please email Claudia Addison at claudia.addison@det.amedd.army.mil for a copy of the RFP. This procurement is unde r full and open competition with no set-asides.
Place of Performance: Address: Chemical and Biological Medical Treatment Systems 64 Thomas Johnson Drive, Attn: Claudia Addison Frederick MD; Zip Code: 21702; Country: US
Record: SN00559225-W 20040404/040402212405 (fbodaily.com)
Source: FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

| FSG Index | This Issue's Index | Today's FBO Daily Index Page |

Loren Data's SAM Daily™

A -- Develop and qualify processes and protocols for high quality, high yield manufacture of pharmaceutical entities in accordance with cGMP and GLP-compiant studies.