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

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