Unraveling the Effects of Filtration, Process Interruptions, and Post-Process Agitation on Protein Aggregation.

Filtration is an essential process step for the manufacturing and filling of biopharmaceuticals. In filling operations, sterile filtration is typically achieved through dead-end filtration using fine membrane filters that completely retain colony-forming units per square centimeter of filter area. According to FDA and USP guidelines, sterilizing filters must be product-compatible and composed of non-fiber releasing materials, typically with a absolute pore size rating of 0.