(609b) De-Risking the Implementation of Single Use Reactors for Antibody-Drug Conjugation Reactions.

Antibody drug conjugates (ADCs) represent a unique biologics modality wherein a monoclonal antibody is conjugated to a small molecule drug-linker. This modality presents unique manufacturing challenges, including potent solids handling, interaction of large and small molecules, and bioburden risk due to aqueous solutions.

As the demand for Antibody Drug Conjugates (ADC’s) increases, the implementation of single-use equipment is vital to optimizing plant productivity. However, concerns regarding inefficient mixing, poor heat transfer, higher sheer rates, oxygen ingress, and extractables have historically prevented the use of single use mixers (SUMs) as conjugation reactors. Significant work has been done to de-risk the scale-up from the lab setup to the production scale SUMs and the transition from the conventional reactors. Both modeling approaches and engineering studies have been applied to provide confidence that the Mobius PowerMix SUM will perform adequately in conjugation processes. This presentation will summarize the efforts in enabling the Mobius PowerMix in clinical ADC programs, sharing the detailed engineering assessment completed.