Single-use systems are attractive for antibody-drug conjugate (ADC) manufacturing because they reduce operator exposure to potent cytotoxins and eliminate cleaning validation between campaigns. However, the organic solvents used in the conjugation step—typically DMA or DMSO at 10–15%—can raise concerns about leachables from plastic and elastomeric components. A sponsored study from Cytiva tested three single-use products under exaggerated conditions to characterise their extractables profiles.
The study covered a ReadyToProcess 1 L column housing, an ÄKTA ready low flow kit, and an ÄKTA readyflux flow kit, using DMA and DMSO at concentrations relevant to ADC processes. For the readyflux flow kit, five organic compounds were found above the reporting limit in each solvent, mostly antioxidants and silicone-related materials; total amounts were similar between solvents, with the most abundant compound a carboxylic acid semi-quantified at 430 µg per kit. Four elements were above reporting limits, with potassium highest at 3.8 mg per kit in 30% DMA.
The column housing showed no organic extractables above the reporting limit by HS-GC-MS or GC-MS; LC-MS detected one compound related to an elastomer curing agent at below 200 µg/L. Element levels were low, with calcium below 100 µg/L and magnesium below 25 µg/L. The low flow kit showed five organic extractables above the reporting limit—two in DMA and three in DMSO—all with confirmed identities.
The authors conclude that the low extractables levels support the use of these single-use products in ADC processes. The article is sponsored content from Cytiva, the manufacturer of the tested products, and the study was designed with advice from customers using disposables in ADC manufacturing. As a single sponsored study, the results have not been independently replicated.