Vaccine

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Manual Rec ROI 800 700 600 500 400 300 200 100 y = 0.9625x R 2 = 0.9998 Extend Enumeration Capabilities (Foci Numbers & ROI) B y = 1.4478x R 2 = 0.9997 0 0 0 100 200 300 400 500 600 Isocyte Rec ROI Manual vs Isocyte Rec vs Rec Isocyte REc vs Circular Linear (Manual vs Isocyte Rec vs Rec) Linear (Isocyte REc vs Circular) � Circular (e.g.~80% of well); >500 foci � Rectangle (e.g. 48% of well); 200 max foci Potency Isocyte (FFU/mL) 4.0 3.8 3.6 3.4 800 3.2 700 3.0 2.8 600 2.6 500 2.4 2.2 400 2.0 300 2.0 2.5 3.0 3.5 4.0 200 100 Isocyte Cirular ROI B Potency Manual (FFU/mL) Iso-Rec Iso-Cir
� PQ and assay validation � Regulatory Approval Implementation in QC
Page 1 and 2:
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: Potency Isocyte (FFU/mL) 4.0 3.8 3.
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 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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