Mixing of a mAb Formulation in a New Magnetically Coupled Single-Use Mixing System: Key Learnings of Preliminary Experimental and Computational Evaluation

Stress Factors in Protein Drug Product Manufacturing and Their Impact on Product Quality

“…When using ML mixers, the use of a minimum mixing speed that ensures levitation may also be beneficial to avoid grinding and associated increases in subvisible particle levels. 39 As shown by multiple studies, the primary modification that can occur during mixing steps with BMMs and stir bars is aggregate/particulate formation (CQAs for all proteins). The protein aggregation mechanisms by mixing stress are mainly associated with foaming and grinding.…”