Process robustness and quality control in ADC manufacturing

“In the future, ADC manufacturing may not even require mAb release testing if it can be integrated.”

In this interview, Lauren Coyle (Launch Commissioning Editor, Bioconjugation Insights), speaks with Brandon Coyle (Director Pivotal Purification Process Development, Gilead Sciences), about the scientific and operational challenges that define ADC development and manufacturing. They explore maintaining comparability across scales and sites, the sensitivity of conjugation to equipment and process changes, and strategies for effective tech transfer, including early robustness work and analytical harmonization.

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