09. - 10. October 2019
Vienna, Austria. International Masterclass Training on "CMC Analytical Comparability in cooperation with Fleming. For participation contact us and find out more about the competencies of Protagen Protein Services (PPS).
Protagen Protein Services is pleased to invite you to our jointly organized event in cooperation with fleming events: CMC Analytical Comparability Training 09. - 10.10.2019 Vienna.
The CMC Analytical Comparability Training provides the opportunity to learn how to define protein analytical projects and critical quality attributes and to set up an analytical strategy for comparability studies.
State-of-the-art analytical methods and concepts are presented. These include topics such as the analytical characterization of biosimilars and reference products, the quality target profile, the acceptable range of variability and the justification of differences. Case studies of originator biologics and biosimilar products, including examples dealing with the development of biosimilar monoclonal antibody products, are discussed. At the end of the two-day Masterclass, participants will understand the latest regulatory requirements and technical aspects for successful development and analytical comparability / similarity studies.
- The global context of Biologics, Biosimilars & Biobetters
- Principles of protein structure and comparative analytics
- How to define the Protein Analytical Program & Critical Quality Attributes
- To design of an analytical strategy for comparability /similarity studies
- New developments in Structure/ Function Relationship
- Protein Characterization according to ICH Q6B