Navigating Your Holistic Approach To Container Closure Integrity For Biologic Drug Products

Regulatory authorities expect demonstration that Container closure integrity (CCI) is maintained throughout product shelf life. Good practice recommends to build CCI into the development, industrialization, lifecycle management, and quality management processes, as opposed to solely testing manufactured items.

Learn why maintaining CCI throughout a parenteral drug product's lifecycle is crucial for safety. This webinar takes participants on a journey, starting with an overview of regulations and expectations and showcasing real-world activities happening from the initial stages all the way through product launch and beyond. A key part is building a dataset that shows how components and manufacturing processes impact CCI, especially during storage and transportation. This data then forms the foundation for a thorough risk assessment. This assessment, in turn, guides various industrialization activities such as equipment qualification tests, defining In-Process Controls (IPCs), and creating a validation package.

Understand the advantages of a comprehensive CCI approach specifically designed for biologic drugs, including monoclonal antibodies (mAbs) and other complex products like fusion proteins or bioconjugates. Gain knowledge of current regulatory expectations and industry best practices for CCI. The webinar equips participants to initiate activities for handling complex cases like combination products in a timely manner.