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� FFA Validated FFA Validated Release Assay Drug Substance & Drug Product Release � Accuracy, precision, LOD, LOQ, specificity, linearity/range, ruggedness, robustness, system suitability � Potency is a quantitative measure of infectivity assessed at a specific time range post-infection � Precision for FFA is better than for a TCID 50 quantal assay � Typically 0.1 – 0.15 log 10 FFU � Typically >0.3 log 10 TCID 50 � Accuracy/specificity requires critical immunoreagents � Potency testing of trivalent drug product needs to distinguish between each vaccine component
FFA Focus Enumeration � Manual counting of foci does not use the entire well � Scan and count across a portion (e.g. ~33%) of the well � Region of interest (ROI) dependent on optical magnification
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: Fix cells Stain with 1 ° Antibody
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 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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