Product quality requirements for medicines make chromatography a central part of the purification process for biopharmaceuticals. In the early days of preparative chromatography, equipment limitations have limited the implementation of gradient elution at large scale. Current equipment allows for robust scale-up. In a first part, several case studies of the use of gradient elution for preparative chromatography of both small molecules and biopharmaceuticals are discussed. Gradient performance and process scale-up are presented to show benefits and to understand limitations. In a second part, the use of gradients as an integrated part of a standard development strategy for mAb and non-mAb molecules is presented. The impact on cost of goods and process development timelines is discussed.

First intent gradient elution for the purification of biopharmaceuticals: Practical approach to accelerate process development and reduce cost of goods</b>

249th National Meeting (2015)

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.