Case Study on Antibody-Drug Conjugate Manufacturing

This case study examines the efforts of Piramal Pharma Solutions to enhance the manufacturing process of antibody-drug conjugates (ADCs) by implementing the Sartoflow® Expert single-use tangential flow filtration (SUTFF) system. The objective was to simplify the ADC processes by reducing the number of skids required for conjugation, filtration, and Con-Di-Con, which traditionally posed challenges in terms of space and connectivity. The study outlines the complexities involved in ADC manufacturing, including the need for operator safety and product integrity due to the toxic nature of the substances processed. The results indicate significant improvements in efficiency, with a reduction in total operator hours from approximately 157 hours to about 50 hours, and a process timeline shortened from 10 days to 3 days. The system achieved a drug-to-antibody ratio (DAR) of 4.1 and a yield of 91.2%, demonstrating its effectiveness in streamlining ADC production while maintaining high-quality standards.