CMC Analytical Comparability Masterclass

Organization: Fleming Europe

Venue: Renaissance Wien

Location: Vienna, Austria

Event Date/Time: Sep 19, 2013 End Date/Time: Sep 20, 2013
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Description

 

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

 

Venue

Linke Wienzeile Ullmannstrasse 71
Vienna
Austria
MORE INFO ON THIS VENUE

Organizations

Fleming Europe