Vaccine

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Summary � Influenza potency measurements assure that seasonal trivalent vaccine products will meet their intended clinical dose effect � The virus surface glycoproteins (HA, NA) are the immunologically relevant antigenic components of influenza vaccines � SRID assay is the standard methods for release of traditional inactivated influenza vaccines � FFA assay is used to measure the infectivity of live attenuated influenza vaccines � Influenza potency assays are critically dependent upon the immunoreagents and reference standards for an accurate assignment of potency
Influenza <strong>Vaccine</strong> Potency Determination and Pandemic Preparedness The BARDA/IED Perspective for USP 2 nd Bioassay Workshop August 13, 2009 Armen Donabedian, PhD Senior Program Manager, <strong>Vaccine</strong>s Advanced Development HHS/BARDA/IED
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USP Bioassay Workshop August 12-13,
Page 3 and 4:
Potency Specific ability or capacit
Page 5 and 6:
Why do we do a potency assay? • I
Page 7 and 8:
Necessary attributes for potency as
Page 9 and 10:
Not everything that counts can be c
Page 11 and 12:
Building the Bridge Clinical Lots M
Page 13 and 14:
Relationship between potency and su
Page 15 and 16: Building the Bridge • In the abse
Page 17 and 18: Development of a potency test: whol
Page 19 and 20: Potency Assays and Vaccines: A Few
Page 21 and 22: Potency and product life cycle •
Page 23 and 24: Potency and the product life‐cycl
Page 25 and 26: U.L. Potency L.L. Calculation of va
Page 27 and 28: U.L. Potency L.L. Calculation of mi
Page 29 and 30: U.L. Potency L.L. Calculation of mi
Page 31 and 32: When is this easier? • Assay prec
Page 33 and 34: A single assay doesn’t always suf
Page 35 and 36: Necessary attributes for potency as
Page 37 and 38: � Influenza Background � Drift
Page 39 and 40: � HA Hemagglutinin � Receptor B
Page 41 and 42: Antigenic Shift Pandemic Influenza
Page 43 and 44: Embryonated Eggs H1N1 � Tradition
Page 45 and 46: � Traditional inactivated vaccine
Page 47 and 48: Seasonal Influenza Vaccines Potency
Page 49 and 50: Live Attenuated Influenza Vaccine I
Page 51 and 52: Fix cells Stain with 1 ° Antibody
Page 53 and 54: FFA Focus Enumeration � Manual co
Page 55 and 56: The IsoCyte Blueshift Biotechnologi
Page 57 and 58: Implementation in QC Lab Technical
Page 59 and 60: Art of staining and manual counting
Page 61 and 62: Extend Enumeration Capabilities (Fo
Page 63 and 64: Potency Isocyte (FFU/mL) 4.0 3.8 3.
Page 65: � PQ and assay validation � Reg
Page 69 and 70: What is BARDA/IED? � Biomedical A
Page 71 and 72: � Vaccines U.S. Pan Flu MCM Strat
Page 73 and 74: Pandemic Influenza Medical Counterm
Page 75 and 76: Ant Assay Based on Bull World Healt
Page 77 and 78: � Proposed Partial Solution Influ
Page 79 and 80: � LC-MS/MS Isotope Dilution LC-MS
Page 81 and 82: BARDA/IED LC-MS/MS LC MS/MS Propose
Page 83 and 84: Development Funding Opportunity Sci
Page 85 and 86: SSTD BAA: Areas of Interest 1. Tech
Page 87 and 88: SSTD BAA: Contact Information Micha
Page 89 and 90: Assessment of Neutralizing Antibodi
Page 91 and 92: Introduction
Page 93 and 94: There are cases in which immune res
Page 95 and 96: Definitions • Antigen - any subst
Page 97 and 98: Antibody structure
Page 99 and 100: -Bind anywhere on the molecule -May
Page 101 and 102: Clinical Significance • In a pati
Page 103 and 104: Evaluating Immunogenicity: A Tiered
Page 105 and 106: Potency Assays used in NAb Assays
Page 107 and 108: NAb Assay Formats • Some assays a
Page 109 and 110: NAb Assays • The incidence of NAb
Page 111 and 112: NAb Assay Sensitivity • The asses
Page 113 and 114: Specificity • Due to the complexi
Page 115: Summary • Patients should be moni
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Vaccine

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