Data-Driven Insights Empower Industry-Backed Approach To Container Closure Integrity

By Fred Bathke, Group Lead Device & Packaging Laboratory Services, and Jean Sebastien Steffen, Group Lead Combination Product & Primary Packaging, Lonza

The pharmaceutical landscape faces increasing challenges: complex molecules, supply disruptions, rising costs, and evolving regulations. This has led to a booming CDMO market, with a wide range of options for outsourcing partners that can offer expertise, experience, and capacity to accelerate drug development.

However, ensuring success requires every CDMO to focus on preserving product quality through stringent quality control measures that can safeguard product integrity throughout development, manufacturing, and shelf life. Despite this, the FDA continues to cite infractions related to sterility or container closure integrity (CCI), leading to a global focus on expanding expectations for CCI in sterile pharmaceuticals. Therefore, while CCI compliance has been traditionally limited to stability and release, it now requires a more holistic approach that aims to incorporate quality control into all phases of product design and development.

In its continued dedication to being a leading outsourcing partner, Lonza collaborated with experts across the industry to detail a comprehensive science- and risk-based approach to CCI for parenteral combination products. This industry-backed approach is now built into Lonza practices throughout its development and manufacturing network, benefiting customers worldwide.