Technical_Requirements_-_Sources_Sought_2015.pdf
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- Solicitation number
- 15-100-SOL-00003
About this file
This document contains a federal sources sought notice and related federal contract opportunity. The Department of Health and Human Services seeks information from qualified small businesses regarding their capability and experience to fulfill future requirements for continued National Pre-Pandemic Influenza Vaccine Stockpile activities. The future requirement is expected to include procurement of influenza vaccine master and working seeds, pilot lots, clinical lots, commercial scale bulk lots, adjuvant bulk lots, formulation, filling, storage, shipping, disposal, testing, reagent and standard manufacture and testing, animal studies, and clinical studies. Respondents are asked to submit capability statements by November 3rd, 2014 referencing solicitation number 15-100-SOL-00003 to the points of contact provided.
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Text version
Technical
Background
The Department of Health & Human Services (HHS) has a future requirement to continue the
National Pre-Pandemic Influenza Vaccine Stockpile: Preparedness and Response activities. The future requirement is expected to include the procurement of cGMP Influenza Vaccine Master and Working Seeds; Influenza Vaccine Pilot Lots; cGMP Influenza Vaccine Clinical Lots;
cGMP Influenza Vaccine Commercial Scale Bulk Lots; cGMP Adjuvant Commercial Scale Bulk
Lots; Formulation and Filling in a variety of containers; Storage and stability; Shipping;
Disposal; Laboratory Testing; Reagent and Standards Manufacture and Testing; Animal Studies;
Clinical Studies and BARDA Tracking tool integration.
Anticipated minimum Mandatory Eligibility Criteria
The anticipated minimum Mandatory Eligibility Criteria for this requirement include that the contractor shall produce vaccines against influenza and influenza strains with pandemic potential; shall demonstrate a successful experience in the manufacturing of influenza vaccine by:
Holding a US influenza vaccine license OR
Have developed an influenza vaccine as evidenced by:
o A pivotal Phase 3 final clinical study report AND o Minutes from a FDA Pre-BLA meeting
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