Enhanced Assurance of Supply for Single-Use Bags: Based on Material Science, Quality By Design, and Partnership with Suppliers

摘要

Growing adoption of single-use bags in commercial production of biopharmaceutical drugs raises new challenges for bag suppliers and drives the need for consistent product quality, improved assurance of supply, robust change management, and business continuity planning. In close collaboration with resin and film suppliers, polymer scientists and biologists at Sartorius Stedim Biotech have followed a stringent material science and quality by design (QbD) program to develop a completely new polyethylenefilm and to achieve consistent performance of new Flexsafe bags for all bioprocess steps and applications.