Leveraging high‐throughput technology to accelerate the time to clinic: A case study of a mAb

Abstract

Acceleration of development timelines to support material production for early‐phase clinical trials has been a continuous goal within the life sciences industry, driven largely by the need to advance an ever increasing number of novel therapeutics into the clinic. This has challenged cell culture and purification development groups to become more efficient, realized in part by leveraging a platform process in the case of mAbs, adopting high‐throughput (HT) technologies, and scaling‐up directly from the HT formats to pilot and clinical scales for toxicology and clinical production. The work presented herein focuses on a case study where a mammalian cell culture process producing mAb A was developed almost exclusively utilizing HT technology. The study describes how HT systems such as microbioreactors for cell culture development and minicolumns driven by robotics for purification development were integrated to rapidly develop a robust production process that was then directly scaled‐up nearly 17 000‐fold for cell culture and 5200‐fold for purification steps to generate material for investigational new drug‐enabling toxicology studies at the 250 L bioreactor scale, followed by another rapid scale‐up to 1000 L for clinical production. Performance comparability across scales demonstrates the effectiveness of HT process development for accelerating the time to clinic.