Immunogenicity and Setting Cut Points

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Immuno-Depletion usingTherapeutic• Specific binding – Antibody totherapeutic product on solid phase(bases of screening assay) is typicallyinhibited by addition of therapeuticproduct in solution.• Non-specific binding – typically isnot altered the same or to the sameextent with addition of therapeuticproduct in solution.36
Switches <strong>and</strong> Balls• The specific inhibition of positivecontrols is much like a light switch.• The non-specific (inhibition orenhancement) of antibody negativesamples is much like pool balls.37
Page 1 and 2: Immunogenicity and SettingCut Point
Page 3 and 4: Screening Cut Point• Definition:
Page 8 and 9: But 5% of the time we hit something
Page 11 and 12: Upper BalconiesHigh PCMiddle Balcon
Page 13 and 14: Upper BalconiesHigh PCMiddle Balcon
Page 15 and 16: Assay Background has 2 VariationCom
Page 17 and 18: Balanced Design for ValidationExper
Page 19 and 20: Balanced Design - includesinhibitor
Page 21 and 22: Types of Screening Cut Points• Fi
Page 23 and 24: Types of Screening Cut Points• Dy
Page 25 and 26: Screening CP Evaluation Flow-Scheme
Page 27 and 28: Distribution & OutliersOriginal Dat
Page 29 and 30: Distribution and OutliersRun 1 Log
Page 31 and 32: How the SD should be calculate?•
Page 33 and 34: Fixed or Floating?Log OD-1-21 2 3 4
Page 35: Floating Cut PointAdditive or Multi
Page 39 and 40: Non-specific inhibition asrepresent
Page 41 and 42: Setting LimitsLowPositiveControlLar
Page 43 and 44: Confirmation Cut PointexampleIndivi
Page 45 and 46: Confirmation Cut PointexampleAll Da
Page 47 and 48: Acknowledgements• Wendell Smith,

Immunogenicity and Setting Cut Points

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