Antibody Drug Conjugates (ADCs) are a class of biomolecules that has seen rapid growth as an oncology therapeutic.  ADCs are comprised of three parts: monoclonal antibody (mAb), linker, and cytotoxic payload, where each component plays a role in therapeutic efficacy. The small molecule linker/payload is a highly potent, toxic agent that requires special consideration for safe handling and containment during conjugation and downstream processing.  To address these concerns, many ADC manufacturers are adopting single use technologies, since they provide isolation and eliminate cleaning operations and carryover risk. However, the transition from traditional manufacturing in stainless steel or glass to single-use poses concern, as the conjugation step commonly utilizes aqueous organic solvents. A better understanding of the compatibility with and extractables from materials of construction is needed to enable widespread adoption of single-use technologies in ADC processing. This poster provides an overview of study design and associated results for evaluation of compatibility and extractables using Mobius® single-use assemblies in the presence of 20% DMSO or 20% DMAc.<br/>

Solvent compatibility and extractables profile for use of Mobius® single-use assemblies in ADC processing

255th National Meeting (2018)

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