Root Cause Investigations for Visible Particles and Aggregation in Drug Containers – Case Studies

16:15 - 16:50

  • The first case study will describe root cause investigations to identify a novel cause for visible particles in polysorbate containing formulations
  • For root cause investigations unconventional approaches may be more successful than the beaten path
  • Broad unbiased screening may be necessary to identify novel causes for unexpected results
  • In a second case study inorganic leachables from a sterile filter were identified as cause for aggregation/particle formation
  • This highlights the importance of a broad method portfolio for characterization of dimers/aggregates/particles and to successfully investigate the root cause of aggregate formation
  • The described findings might be relevant in general for biologics drug product development and will contribute to the improved quality of biopharmaceuticals

Andreas Seidl, Head Global Analytical Characterization & Bioanalytics , Hexal (Novartis)