The growing importance of cleaning validation in ADC biologics manufacturing
The growing importance of cleaning validation in ADC biologics manufacturing, authored by Mark Studer, Pilho Park, and Myunghee Song, explores a critical challenge facing the pharmaceutical industry. As ADC pipelines accelerate — with 430 studies active in the US alone — the complexity of manufacturing highly potent linker–payload compounds demands a fundamental rethink of cleaning validation. Unlike conventional biologics, even trace cytotoxic residues can compromise product quality and increase cross-contamination risk.
The authors examine how integrated containment strategies, high-sensitivity LC–MS/MS detection, and streamlined FIA–MRM approaches are setting new standards for lean yet robust validation, cutting false negatives by over 90% while enabling safe, multi-product facility operations.
Read the full article on Manufacturing Chemist for in-depth insights and technical case studies.
The growing importance of cleaning validation in ADC biologics manufacturing, authored by Mark Studer, Pilho Park, and Myunghee Song, explores a critical challenge facing the pharmaceutical industry. As ADC pipelines accelerate — with 430 studies active in the US alone — the complexity of manufacturing highly potent linker–payload compounds demands a fundamental rethink of cleaning validation. Unlike conventional biologics, even trace cytotoxic residues can compromise product quality and increase cross-contamination risk.
The authors examine how integrated containment strategies, high-sensitivity LC–MS/MS detection, and streamlined FIA–MRM approaches are setting new standards for lean yet robust validation, cutting false negatives by over 90% while enabling safe, multi-product facility operations.
Read the full article on Manufacturing Chemist for in-depth insights and technical case studies.
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