Extractables In Single-Use Systems Used In ADC Manufacturing

Single-use (SU) systems show significant promise for antibody-drug conjugate (ADC) manufacturing. However, the use of organic solvents in the ADC process raises concerns about potential leachables from the plastic and elastomeric materials in SU components. To address these questions, extractables studies were conducted on a disposable chromatography column housing as well as two different disposable flow paths. These studies utilized two solvents commonly employed in the ADC cytotoxin conjugation step: DMA and DMSO.

The study conditions were intentionally designed to be more extreme than typical ADC manufacturing processes. Extractable organic compounds and trace elements from the SU components were identified and semi-quantified using a range of analytical techniques. The low levels of extractables detected in this study support the use of ReadyToProcess™ columns, ÄKTA readyflux™ flow kits, and ÄKTA ready™ flow kits in ADC manufacturing processes.