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2020 - Method Development and Validation for Assays Supporting Testing of Biologics
Date2020-04-02 - 2020-04-03
Deadline2020-03-23
VenueOrlando, FL, USA - United States 
KeywordsELISA; Immunogenicity methods; Analytical CMC methods
Topics/Call fo Papers
Understanding the different requirements for small versus large molecules
Mapping appropriate timelines with decision points
Designing, developing, optimizing, and validating key methods
Potency methods, other release and stability methods
Preclinical and clinical methods
Use of DOE and statistical analysis
Handling of critical materials
Process monitoring concepts
Assessment of orthogonal methods
Assessing readiness for validation
Defining the validation protocol with real-time capture of data analysis
Maintaining quality through documentation
Mapping appropriate timelines with decision points
Designing, developing, optimizing, and validating key methods
Potency methods, other release and stability methods
Preclinical and clinical methods
Use of DOE and statistical analysis
Handling of critical materials
Process monitoring concepts
Assessment of orthogonal methods
Assessing readiness for validation
Defining the validation protocol with real-time capture of data analysis
Maintaining quality through documentation
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Last modified: 2020-02-11 06:08:55