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SAMDAILY.US - ISSUE OF APRIL 12, 2020 SAM #6709
SOLICITATION NOTICE

A -- Clinical Trial Materials for Virus Vaccines

Notice Date
4/10/2020 1:30:56 PM
 
Notice Type
Presolicitation
 
NAICS
541714 — Research and Development in Biotechnology (except Nanobiotechnology)
 
Contracting Office
NIH NIAID DEA OA OFC ACQUISITIONS BETHESDA MD 20892 USA
 
ZIP Code
20892
 
Solicitation Number
RFP75N93020R00008
 
Archive Date
05/01/2020
 
Point of Contact
Uju Obii-Obioha, Phone: 3017616540, Sevag Kasparian, Phone: 2406695177
 
E-Mail Address
uju.obii-obioha@nih.gov, sevag.kasparian@nih.gov
(uju.obii-obioha@nih.gov, sevag.kasparian@nih.gov)
 
Description
The purpose of this acquisition is to establish an appropriate current Good Manufacturing Practice (cGMP) Contract Manufacturing Organization (CMO) to support rapid vaccine development by manufacturing vaccine Clinical Trial Materials (CTM) for trials of live-attenuated virus or inactivated virus vaccine candidates.� Vaccine ancillaries or other biologics required to advance to clinical trials, such as virus challenge stocks, diluents, cell lines for use in the production of the vaccines, test materials, etc., are also within scope. Mandatory Qualification Criteria include: CMO with fully developed cGMP compliance systems.� All CTM manufacturing activities are required to comply with cGMP. Required offeror capabilities: Capability for producing live virus drug substance in cultured mammalian cells. Capability for producing live virus drug substance in specific-pathogen-free (SPF) eggs. Evaluation Criteria shall include suitability of technical approach, principal technical staff, and facilities for capability and capacity to meet the SOW requirements.
 
Web Link
SAM.gov Permalink
(https://beta.sam.gov/opp/d28066d8c5a14e27bbea3aa76607584e/view)
 
Record
SN05617456-F 20200412/200410230143 (samdaily.us)
 
Source
SAM.gov Link to This Notice
(may not be valid after Archive Date)

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