Author Archives: Carole Langlois

Ensuring the Integrity of Single-Use Containers: Providing Robustness, Science, and Helium-Based Technology with a Detection Limit of 2 μm

Identifying the greatest defect size, both for liquid leaks and microbial ingress, is a fundamental step toward protecting the integrity of single-use systems (SUS) under real process conditions. Integrity testing of such systems may become a prerequisite in the future because they are used in the most critical process steps, with detection limits correlating to liquid leaks and microbial ingress. Such testing guarantees the sterility of drug substances and drug products packaged in single-use systems and, therefore, enhance patient safety.…

Exploring the Science Behind Single-Use Container–Closure Integrity Assurance

Failures in the integrity of single-use systems during commercial manufacturing can cause a number of serious problems for biomanufacturers. A loss of system integrity during processing can allow environmental contaminants that can be dangerous for patients (e.g., microbes) to enter a process. Biopharmaceuticals and their intermediates can be highly potent or even infectious agents, so an integrity failure can jeopardize the safety of operators. In severe cases when biomanufacturers cannot ensure the quality of drug products for fear of a…

Outsourcing to Enhance Assurance of Supply: Application of Counterintuitive Supply Chain Strategies — A Case Study

Single-use technologies have transformed biopharmaceutical manufacturing by providing tremendous and proven opportunities to reduce costs, improve flexibility, and shorten cycle times. The expansion of such technologies into commercial production has naturally raised new challenges for both end users and suppliers, thus driving the need for a critical look at risks associated with their use. End users now face a new challenge: how to assess their own supply chains for robust assurance of supply. What is the suppliers’ responsibility in addressing…

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

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 polyethylene film and to achieve consistent performance of new Flexsafe bags…