Application Note

Extractables Studies For Single Use Systems Used In ADC Manufacturing

Source: GE Healthcare Life Sciences
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.