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CMC Analytical Comparability

Methods & Strategies for Biologics, Biosimilars & Biobetters

  • 09/10/2019 - 10/10/2019
  • Vienna, Austria

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Key Topics

Analytical Comparability of Biologics, Biosimilars & Biobetters

The analytical strategies of protein characterisation of Biosimilars

Comparability in Biosimilar Development

New developments in structure/function relationship

In vitro pharmacology

The structure of the protein

Training features:

Understand

  • The global context of Biologics, Biosimilars & Biobetters
  • Principles of protein structure and comparative analytics

Learn

  • How to define the Protein Analytical Program & Critical Quality Attributes
  • To design of an analytical strategy for comparability /similarity studies

Gain

  • New developments in Structure/ Function Relationship
  • Protein Characterization according to ICH Q6B

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Delegate Fee

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