Vaccine

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Neutralizing Antibodies (NAbs) Cell Activation -NAbs are a subset if BAbs -Binding inhibits receptor/ligand interactions -Inhibit protein activity in a bioassay -Detected using a bioassay
Clinical Significance • In a patient both BAbs and NAbs can lead to loss of efficacy and/or negatively impact safety, therefore both may be clinically important • NAbs may be more effective in directly impacting efficacy – IL-2 and IFN-b higher titers of NAbs are associated with loss of efficacy
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USP Bioassay Workshop August 12-13,
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Potency Specific ability or capacit
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Why do we do a potency assay? • I
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Necessary attributes for potency as
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Not everything that counts can be c
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Building the Bridge Clinical Lots M
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Relationship between potency and su
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Building the Bridge • In the abse
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Development of a potency test: whol
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Potency Assays and Vaccines: A Few
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Potency and product life cycle •
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Potency and the product life‐cycl
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U.L. Potency L.L. Calculation of va
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U.L. Potency L.L. Calculation of mi
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U.L. Potency L.L. Calculation of mi
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When is this easier? • Assay prec
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A single assay doesn’t always suf
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Necessary attributes for potency as
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� Influenza Background � Drift
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� HA Hemagglutinin � Receptor B
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Antigenic Shift Pandemic Influenza
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Embryonated Eggs H1N1 � Tradition
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� Traditional inactivated vaccine
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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 and 66: � PQ and assay validation � Reg
Page 67 and 68: Influenza Vaccine Potency Determina
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: -Bind anywhere on the molecule -May
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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