Study shows low extractables in single-use components support ADC manufacturing

Cytiva conducted extractables testing on disposable chromatography column housings and flow kits used in antibody-drug conjugate production.

The tests used dimethylacetamide (DMA) and dimethyl sulfoxide (DMSO), solvents common in the cytotoxin conjugation step, and applied exaggerated conditions to challenge the materials.

Analytical results identified only trace amounts of organic compounds and elements, indicating that the single-use parts, such as ReadyToProcess columns and AKTA flow kits, introduce minimal leachables.

The findings support the continued use of these single-use systems in ADC processes, addressing concerns about plastic and elastomer leachables when organic solvents are employed.