May 18, 2017

Extractables Studies for Single‑Use Systems Used in ADC Manufacturing


Single‑use (SU) systems have great potential in antibody‑drug conjugates (ADC) manufacturing. The use of organic solvents in the ADC process might , however, raise questions about potential leachables from the plastic and elastomeric materials of single‑use components. To address those concerns, extractables studies were
performed on disposable chromatography column housings and disposable flow paths provided by GE Healthcare. The extractables studies were performed with two solvents commonly used in the ADC cytotoxin conjugation step, DMA and DMSO. The studies were designed to ensure that conditions were exaggerated compared to existing ADC manufacturing processes. Extractable organic compounds and trace elements from the single‑use components were identified and semi‑quantitated with a complementary set of analytical techniques. The low levels of extractables found in this study support the use of ReadyToProcess™ columns and ÄKTA™ ready Flow Kits in ADC processes.

Download the application note.

Tags: chromatography, filtration, tangential flow, diafiltration, DF, ultrafiltration, UF, bioprocessing, manufacturing, conjugate, antibody, disposables, single-use, Extractables