August 26, 2022

Quality by design in biotherapeutics purification white paper

Learn how understanding and addressing variability sources can help you develop robust chromatography processes. The principles and methodologies of biopharmaceutical manufacturing are well established today. However, the increased molecular diversity brings new challenges for biomanufacturers. One of these challenges is how process developers might gain a deeper understanding for sources of variability and set mitigation strategies. This white paper summarizes information around resin variability, serving as a reference and providing support for developing robust purification processes for biopharmaceuticals.


Tags: process development, raw material characterization, process characterization, chromatography, downstream, Quality By Design, QbD