Purification Process Development with Monoliths: II. Column Loading

P. Gagnon

Roadmap to Process Development, issue 2/2009, Sartorius BIA Separations

Introduction

Determination of column loading capacity is a critical component of purification process development. Its most obvious link is to process economics, since the more product that can be loaded per unit of media volume, the smaller the column and volume of buffers, and the smaller the process footprint (manufacturing space requirement). But binding capacity is also linked directly to loading conditions, and beyond that, loading is a key determinant of purification performance and reproducibility. In practice, determination of optimal loading is tedious, time consuming, and expensive, especially due to the large amounts of sample it requires. This makes it all the more important to get it right the first time.

The objectives of this article are to highlight the process considerations that pertain to loading, and to provide you with a set of practical tools to determine capacity values that are meaningful in your particular usage context.