SPECIAL NOTICE
A -- Program for Stability Testing for Malaria Vaccine Products
- Notice Date
- 8/29/2012
- Notice Type
- Special Notice
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, Naval Medical Research Center, 503 Robert Grant Ave., Contracting Dept, Bldg 500, Silver Spring, Maryland, 20910, United States
- ZIP Code
- 20910
- Solicitation Number
- N3239812RCAR003
- Archive Date
- 9/25/2012
- Point of Contact
- Deborah M. Sharpe, Phone: 3013197321
- E-Mail Address
-
deborah.sharpe@med.navy.mil
(deborah.sharpe@med.navy.mil)
- Small Business Set-Aside
- N/A
- Description
- The Naval Medical Research Center (NMRC) intends to award a contract on a sole source basis to GenVec Inc., 65 West Watkins Mill Road, Gaithersburg, MD 20878 to procure the services of a Contract Manufacturing Organization (CMO) to maintain a stability testing program enabling ongoing product development for malaria vaccine products and conduct a clinical study for the clinical trial material ((=Vaccine Drug Product) comoprising the NMRC-M3V-Ad-PfCA Vaccine, namely the two adenovectors (1) NMRC-M3V-Ad-PfC (lot number FPCSP-002) and (2) NMRC-M3V-Ad-PfA (lot number FPAMA1-002). Stability time points for 84 months, 96 months, and 108 months (end of clinical use) will be performed under this contract). GenVec is the sole proprietary holder of the GV11 vector and compatible helper cell line (293orf6) required to produce adenoviral practices for the Government's construct. GenVec is the leader in the field of Adenoviral production for use in clinical and preclinical studies and they have all the biosafety level rated facilities for the safe production and testing of these adenovirus constructs. The stability testing required by the Food and Drug Administration (FDA) has been performed by GenVec since they manufactured and released the products in 2004-2005. GenVec is considered the only supplier capable of meeting the minimum requirements specified by the Government. Although other companies may be able to perform the testing services, GenVec Inc. was the co-creator (with NMRC malaria investigators) and manufacturer for this vaccine product and therefore, maintains the contract manufacturing information on file with the FDA and is the only company who can provide the specific testing expertise for NMRC. Services for this contract will be performed at the contractor's site. This acquisition is to procure the services of a CMO contractor to produce a program for stability testing for malaria vaccine products and research investigational malaria vaccines in clinical and nonclinical trials. The NMRC Infectious Diseases Directorate, Malaria Department serves as the Navy's center for research and development efforts related to combating relevant infectious disease threats. NMRC conducts basic and applied research in the biomedical sciences including Infectious Diseases. The contractor may be required to conduct the following tasks: (1) Stability Program for Vaccine Drug Products LN FPCSP-002 and LN FPAMA1-002 (NMRC-M3V-Ad-PfCA Malaria Vaccine Clinical Lots) and (2) Support of Regulatory Activities related to protocols associated with tsting vaccines and its components. The contractor will be required to provide Stability Reports, Final Stability Reports, and Regulatory Documentation. The Government will award a Firm Fixed Contract. An award will be made within fifteen (15) days from the date of this notice. Sources may submit a quote that demonstrates their capabilities, which will be considered by the agency. A determination to compete this procurement based on a response to this notice is solely within the discretion of the Government. All responses or questions regarding this post must be in writing and can be sent via email to Deborah.Sharpe@med.navy.mil. No phone calls will be accepted. This sole source procurement will be awarded as a simplified acquisition for commercial items in accordance with FAR Subpart 13.5. Quotes are due on September 10, 2012 at 3:30 pm EST. All questions/inquiries must be submitted to the contract office via electronic mail (e.mail) no later than 3:30 pm EST on September 4, 2012. Inquiries submitted via telephone calls will be re-directed to an email submission. Submit quotes or any questions to the attention of Deborah Sharpe via email to Deborah.Sharpe@med.navy.mil.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/1fd1c843f15ead14a156f822c63f729c)
- Place of Performance
- Address: 65 West Watkins Mill Road, Gaithersburg, Pennsylvania, 20878, United States
- Zip Code: 20878
- Zip Code: 20878
- Record
- SN02860512-W 20120831/120830000053-1fd1c843f15ead14a156f822c63f729c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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