Leveraging CDMO Expertise: A Case Study in Achieving Aseptic Fill/Finish Success

By David King, Director of Drug Product Operations, Samsung Biologics

Achieving high-quality drug product requires a combination of meticulous quality control measures, personnel expertise, and judicious application of technology — benefiting patients and the industry. Samsung Biologics recently targeted expedited technology transfers, reduced false rejection rates, and enhanced collaboration with our clients as just a few areas where we can further enhance our services to better serve customers across the globe.

For every issue with the potential to delay DS-to-DP conversion, vial filling, quality inspection, or any other process, a holistic approach to identifying root causes and mitigating them is essential. The project sponsor and its CDMO partner must work together as a single entity to achieve common goals — sharing a commitment to quality, efficiency, and innovation, and reinforcing that commitment through constant communication and collaboration. The partnership’s effectiveness is bolstered even more when the CDMO has the expertise and resources to implement that shared vision seamlessly.