With high attrition rates of mAbs in early phase clinical trials, it is becoming increasingly challenging for biopharmaceutical companies to rapidly deliver high quality therapeutic mAbs using conventional antibody screening and fed-batch bioprocessing methods. This is why new Quality by Design (QbD) approaches such as using in silico AI and ML platforms to discover and optimize mAb sequences, high-throughput screening, and continuous intensified manufacturing processes such as those used at Just- Evotec Biologics are critical for enabling a paradigm shift in reducing attrition rates.
As detailed in this article, optimizing mAb design, using automated, miniaturized screening, and minimizing time in culture can deliver high-quality mAbs for FIH trials in rapid response times of around 12 months. In the future using this approach could expand access to life changing treatments, as well as support a rapid response to global health emergencies.