Meeting The Process Development Challenges Of A Diverse Biologic Pipeline

By Mats Lundgren, Cytiva

How to navigate the evolving biopharmaceutical landscape from a process development standpoint

The biopharmaceutical industry has been growing and evolving at a pace that’s hard to match, especially in terms of manufacturing. Gone are the days when developers looked at monoclonal antibodies (mAbs), or antibodies that are made by identical immune cells cloned from a single cell, as a challenge – rather, mAbs have become an industry standard, with well-established research, development, and manufacturing processes that have proven to be robust and scalable. In the current biopharmaceutical landscape, developers are constantly encountering new and diverse biological molecules with complex structures. While these novel biologics are filling drug pipelines, they are also challenging existing manufacturing processes, both in upstream, downstream and analytical development.

Understanding what challenges these diverse molecules can create and how to manage these challenges is key to ensuring they reach patients safely and efficiently.