CLIN_Capability_Summary_-_Sources_Sought_-_Stockpile_2015.pdf
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- Solicitation number
- 15-100-SOL-00003
About this file
This document contains a capability summary chart and a sources sought notice for a federal contract opportunity related to medical countermeasures for pandemic influenza preparedness and response. The chart lists 18 contract line item numbers (CLINs) pertaining to influenza vaccine and adjuvant development, manufacturing, storage, shipping, testing, and reporting. The sources sought notice seeks information from small businesses regarding their capability and size to fulfill the requirements, which include cGMP influenza vaccine master seed lots, clinical and commercial bulk vaccine lots, adjuvant bulk lots and formulation, filling, storage of bulk and final products, shipping, candidate vaccine viruses, potency reagents and testing, animal studies, clinical studies, disposal, and additional reporting. Responses are due by September 15, 2015 and must reference solicitation number 15-100-SOL-00003 and be submitted to the named contracting staff at the Department of Health and Human Services.
CLIN Capability Summary - Influenza Stockpile
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Other files
| File | Type | Posted |
|---|---|---|
| Technical_Requirements_-_Sources_Sought_2015.pdf | ||
| Statement_of_Work_-_Influenza_Stockpile_(9-30-14).pdf |
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Text version
Chart 1: CLIN Capability Summary – Sources Sought - Stockpile 2015
LEGEND
“Y” = have capability “N” = do not have capability
“N/A” = Not applicable
CLINs
H av e
C ap ab ili ty
N o te s
CLIN 0001: cGMP Influenza Vaccine Master and Working Seed Lot
CLIN 0002: Influenza Vaccine Development Lot(s)
CLIN 0003: cGMP Influenza Vaccine Clinical Lot (s)
CLIN 0004: cGMP Influenza Vaccine: Commercial Scale Bulk Lot(s)
CLIN 0005: cGMP Adjuvant Commercial Scale Bulk Lot(s)
CLIN 0006: Formulation and Filling
CLIN 0006A: Antigen: Single Dose Vials
CLIN 0006B: Antigen: Syringes or sprayers
CLIN 0006C: Antigen: Multi-dose vials
CLIN 0006D: Adjuvant: Single Dose Vials
CLIN 0006E: Adjuvant: Multi-dose Vials
CLIN 0006F: Co-formulated antigen and adjuvant: Single Dose Vials
CLIN 0006G: Co-formulated antigen and adjuvant: Syringes or Sprayers
CLIN 0006H: Co-formulated antigen and adjuvant: Multidose Vials
CLIN 0007: Storage and Stability
CLIN 0007A: Storage of clinical bulk lots of antigen
CLIN 0007B: Storage of commercial bulk lots of antigen
CLIN 0007C: Storage of antigen in final container
CLIN 0007D: Storage of adjuvant bulk
CLIN 0007E: Storage of adjuvant in final container
CLIN 0007F: Storage of licensed product in final package
CLIN 0008: Shipping
CLIN 0009: Candidate Vaccine Virus (C V V)
CLIN 0010: Potency reagent and standards manufacture and testing
CLIN 0011: laboratory Testing/Assay
CLIN 0012: Animal Studies
CLIN 0013: Clinical Studies
CLIN 0014: Disposal of Product
CLIN 0015: BARDA Tracking Tool Development and Testing of New Standard Data Reporting Formats
CLIN 0016: Additional Reporting
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