2017-CLIN_Capability_Summary.pdf

Chart 1: CLIN Capability Summary – Sources Sought - Stockpile 2017

LEGEND

“Y” = have capability “N” = do not have capability

“N/A” = Not applicable

CLINs Have

Capability Notes

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: Multi-dose Vials

CLIN 0007: Storage and Stability

CLIN 0007A: Storage/stability of clinical bulk lots of antigen

CLIN 0007B: Storage/stability of commercial bulk lots of antigen

CLIN 0007C: Storage/stability of antigen in final container

CLIN 0007D: Storage/stability of adjuvant bulk

CLIN 0007E: Storage/stability of adjuvant in

CLIN 0007F: Storage/stability of licensed product in final package

CLIN 0008: Shipping

CLIN 0009: Candidate Vaccine Virus (CVV)

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

CLIN 0017: Storage and stability of materials from prior contracts

CLIN 0017A: Storage/stability of bulk lots of antigen

CLIN 0017B: Storage/stability of antigen in

CLIN 0017C: Storage/stability of bulk lots of adjuvant

CLIN 0017D: Storage/stability of adjuvant in