Protagen Protein Services is pleased to invite you to our co-organized event in cooperation with fleming: CMC Analytical Comparability Training 8.-9.10.2018 Vienna, Austria Trend Hotel Doppio Learn how to define protein analytical program & critical quality attributes, to design an analytical strategy for comparability studies, the global context of biologics, biosimilars & bio-betters, and new developments in function relationship.

The CMC Analytical Comparability Training -Methods And Strategies For Biosimilars And Biobetters - is a platform to learn how to define protein analytical program & critical quality attributes, to design an analytical strategy for comparability studies, the global context of biologics, biosimilars & bio-betters, and new developments in function relationship. The training will provide a comprehensive overview of the phase-specific requirements for CMC analytical characterization, comparability.

Chemistry, Manufacturing, and Controls (CMC) constitutes that part of pharmaceutical development that deals with the nature of the drug substance and drug product.

 

Key Topics: 

  • Analytical Comparability of Biologics, Biosimilars & Biobetters
  • Comparability in Biosimilar Development
  • The analytical strategies of protein characterisation of Biosimilars
  • New developments in structure function relationship
  • The structure of proteins
  • In vitro pharmacology


Learn more about Protein Characterization according to ICHQ6B at our CMC Analytical Comparability

Assess which Biotech/Biosimilar Analytical Comparability Studies are needed for accurate and reliable results.

 

Participants will be introduced to state-of-the art analytical methods and concepts. This will include topics such as analytical characterization of biosimilar and reference product, quality target product profile, acceptable range of variability, and justification of differences. Case studies of originator biologics and biosimilar products incl. examples addressing the development of biosimilar monoclonal antibody products will be discussed. At the end of the 2 day Masterclass, the participants will understand the latest regulatory requirements and technical aspects for successful development and analytical comparability / similarity studies.

KEY TOPICS

  • Analytical Comparability of Biologics, Biosimilars & Biobetters
  • Protein Characterisation
  • The analytical strategies of protein characterisation of Biosimilars
  • New developments in structure function relationship
  • The structure of proteins
  • In vitro pharmacology

TAKE AWAYS from interactive 2-day workshop

  • All delegates will receive comprehensive course documentation for use during the program
  • 5H+ of Networking with other industry experts
  • Round table discussions
  • Case studies
  • Interactive learning approach
  • Hands-On case studies from the trainer‘s experience

https://www.xing.com/events/cmc-analytical-comparability-training-1972314

https://fleming.events/cmc-analytical-comparability-training/