Understanding Particulates in Single-Use Bags: Their Relationship to USP Chapter <788>

摘要

The biopharmaceutical industry is facing many challenges. Global economic changes, increasing healthcare costs, expiring patents, and increasingly personalized medicine all affect the way manufacturers approach bioprocessing steps and the equipment and systems used to make biological drug products (l). Demands for smaller batch sizes, greater process flexibility, reduced manufacturing costs, and increased speed to clinic have driven the acceptance of single-use systems (SUSs) in this industry (Figure 1). SUS suppliers have rapidly developed components such as fittings, tubing, pumps, sensors, and flexible containers that are delivered to users presterilized and ready for use in single campaigns or process steps.