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FBO DAILY ISSUE OF JUNE 16, 2011 FBO #3491
SOLICITATION NOTICE

R -- Continued Eukaryotic Bank Storage cGMP Up to 650 Vials of MDCK and Vero Bank

Notice Date
6/14/2011
 
Notice Type
Combined Synopsis/Solicitation
 
NAICS
541990 — All Other Professional, Scientific, and Technical Services
 
Contracting Office
Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
 
ZIP Code
30341-4146
 
Solicitation Number
00HCVGDD-2011-98074
 
Archive Date
6/22/2011
 
Point of Contact
Linda M Young, Phone: (770) 488-2655
 
E-Mail Address
lml3@cdc.gov
(lml3@cdc.gov)
 
Small Business Set-Aside
N/A
 
Description
The Centers for Disease Control and Prevention intends to issue a sole source purchase order to BioReliance Corporation, 14920 Broschart Road, Rockville, MD 20850-3304 for continued cGMP biorepository storage. Background and Need – Tissue culture cells used in production of influenza vaccine seed stock development must be handled under Good Laboratory Practice (GLP) or current Good Manufacturing Process (cGMP) conditions. Frozen stocks of such cells need to be stored under specific, well-documented, and certified conditions in order to meet GLP/cGMP regulations. The laboratory has several hundred vials of tissue culture cells (Vero and MDCK cells) stored in liquid nitrogen under cGMP conditions. This is a continuing requirement without which we will be unable to produce GLP-quality vaccine seed stocks. Scope of Work –Tissue culture cells will be stored in a liquid nitrogen biorepository. All conditions must meet or exceed those defined in cGMP regulations, including certifications of sterility. Technical Requirements – Up to 2000 vials of Vero and MDCK cells, and of other cell lines that may be described, will be stored in a liquid nitrogen biorepository. Storage conditions must be constantly monitored to ensure safe storage. All conditions must meet or exceed those defined in cGMP regulations, including certifications of sterility. Cells and appropriate documentation must be delivered to the Molecular Virology and Vaccine Branch, Influenza Division, CDC (MVVB) on request. Reporting Schedule – Documentation of number of vials and storage conditions must be provided on request. Any transfer would require taking place under controlled conditions that comply with cGMP requirements in order to avoid significant risk of damage to or loss of the cells during the transfer as well as disruption of continuity of documentation. Quarterly and yearly reports may be required. CDC plans to award this requirement as a one year service with four one-year options. CDC believes that this requirement is met by only one provider. This procurement will be processed under the authority of FAR 6.302-1 and 6.302-2. Only one responsible source and no other sources will satisfy agency requirements. No solicitation is being issued. Interested persons may identify their interest and capability to respond to this requirement. This procurement is not set-aside for small business. For contractual questions contact Linda M. Young.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/00HCVGDD-2011-98074/listing.html)
 
Place of Performance
Address: 1600 Clifton Road, Building 17, Room 5048, Atlanta, Georgia, 30333, United States
Zip Code: 30333
 
Record
SN02472781-W 20110616/110614235431-63551bb341855b2aa0356a35c6e5092b (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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