The study centers on the transition from "traditional" process development to an enhanced QbD approach. It leverages guidelines from the International Council for Harmonisation (ICH), specifically (Pharmaceutical Development), Q9 (Quality Risk Management), and Q10 (Pharmaceutical Quality System).
Throughout this case study, principles drove development. For A Mab, the critical quality attributes (CQAs) were: A Mab A Case Study In Bioprocess Development