SOLICITATION NOTICE
99 -- Development, Preparation, cGMP Manufacture and Testing of Antiplaque Chewing Gum Containing Antimicrobial Peptides for Phase I Clinical Trial
- Notice Date
- 6/26/2009
- Notice Type
- Presolicitation
- NAICS
- 325411
— Medicinal and Botanical Manufacturing
- Contracting Office
- Department of the Army, U.S. Army Medical Research Acquisition Activity, U.S. Army Medical Research Acquisition Activity, US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-09-T-0397
- Response Due
- 7/27/2009
- Archive Date
- 9/25/2009
- Point of Contact
- Dana Herndon, 301-619-7140<br />
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(dana.herndon@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- This acquisition will be a firm-fixed-price commercial service for the Development, Preparation, cGMP Manufacturing and Testing of Antiplaque Chewing Gum Containing Antimicrobial Peptides for Phase I Clinical Trial. This service shall be performed for the U.S. Army Dental and Trauma Research Detachment (USADRTD), a detachment of the Walter Reed Army Institute of Research (WRAIR). The USADRTD has developed several candidate antimicrobial peptides that could be used for controlling plaque-associated oral infection, including dental caries. The USADTRD is particularly interested in developing antimicrobial systems that could be incorporated into the military field ration, specifically into chewing gum. Their use of this novel antiplaque chewing gum could significantly reduce the incidence of dental emergencies among deployed forces by controlling plaque formation, allowing sustained operations in extreme environments while maintaining mission capabilties. In pursuit of this objective, the USADTRD is interested in the dvelopment and manufacturing of small scale current Good Manufacturing Practice (cGMP) antiplaque chewing gum containing USADTRDs antimicrobial peptide (KSL-W) and cetylpyridinium chloride (CPC), which exhibit broad-range bactericidal activities, to be used in the oral cavity for improving the oral health of the deployed soldiers. In conjunction with this effort, the USADTRD is interested in determing the stability of this prototype cGMP antiplaque chewing gum and the release kinetics of the bacteria-fighting agent from the gum formulations. The specific objective of the requirement is to manufacture, according to current Good Manufacturing Practices (cGMP) and the U.S. Code of Federal Regulations (CFR) Parts 210 and 211, a Phase I Lot of Antiplaque Chewing Gum (APCG) with associated internal Quality Assurance (QA) and Quality Control (QC) reviews, for use in nonclinical animal and human clinical studies, as defined and summarized in the Quality System Plan (provided in the RFQ) which identifies the roles and responsibilities of the US Army and Manufacturer. Contract Requirements: All work to be accomplished under this Contract shall be in accordance with the requirements of the contract and in strict accordance with the contract technical specifications. One contract shall be awarded on a Best Value basis to the offeror whose proposal is considered most advantageous to the government given its responsiveness to all aspects and requirements of the solicitation and considering price and other non-price related factors. The North American Industry Classification System (NAICS) code for this acquisition is 325411. The RFQ will be available for downloading at the Army Single Face to Industry website at https://acquisition.army.mil/asfi on or about 6/26/2009. No paper copies of the solicitation will be mailed and telephone requests will not be honored. Contractors must be registered in the Central Contractor Registration (CCR), accessed via the Internet at http://www.ccr.gov. Offerors pricing and Representations and Certifications shall be submitted electronically. All responsible, responsive, and timely proposals will be considered for award. Questions regarding this solicitation may be sent to Dana Herndon, Contract Specialist, at e-mail address, dana.herndon@us.army.mil.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH-09-T-0397/listing.html)
- Place of Performance
- Address: US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD<br />
- Zip Code: 21702-5014<br />
- Zip Code: 21702-5014<br />
- Record
- SN01857927-W 20090628/090626235710-5a6a605b0bf3415147d865d16f363a08 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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