Bioconjugation Scale-Up: Data-Driven Strategies From 10 L To 500 L

Scaling ADC bioconjugation from the bench to production requires more than increasing vessel volume. Mixing and temperature must remain tightly controlled to protect critical quality attributes, including drug-to-antibody ratio (DAR) and aggregation. Data from 10 L, 100 L, and 500 L scales demonstrate how scalability tools can establish equivalent processing conditions at each step. The analysis also examines the performance of single-use components when exposed to organic solvents commonly used in ADC manufacturing. At production scale, a value assessment compares the cost and operational impact of single-use bioconjugation, including its potential to simplify setup, reduce cleaning requirements, and improve facility flexibility.

Explore the supporting data and see how a structured, data-driven approach can help reduce risk during ADC process scale-up.