INTRODUCTION: Advances in Process Chromatography The past, present, and possible future of process-scale chromatography

Process-scale chromatography has been an indispensable component of the biotechnology industry since the earliest days of recombinant DNA technology, when laboratory techniques were scaled up for the large-scale purification of insulin. In the thirty years since these first developments, there have been many advances in the design of columns, the creation of better-performing resins, and in the processes themselves. Today we have an embarrassment of riches, with alternative column technologies such as radial flow and expanded beds becoming accessible and practical on larger scales, the rational design of more efficient affinity ligands, and the rise of disposable membrane chromatography and monoliths as a viable alternative to traditional packed-bed columns.

Uwe Gottschalk

In this special supplement to BioPharm International, we present a mixture of articles reviewing the history of process chromatography, discussing the relative merits of various chromatography systems, and showcasing some new and exciting technological developments. We begin with a thoughtful historical review by John Curling of John Curling Consulting AB, charting the development of process-scale chromatography from its beginnings in the food industry to its staple position in biopharmaceutical production today. Gail Sofer and Mattias Ahnfelt of GE Healthcare then discuss the concept of validation in process chromatography and how this has developed from batch certification into a lifecycle approach to facilitate continuous improvement.

Articles follow by Joe Zhou and colleagues from Amgen Inc., discussing the relative merits of column chromatography and membrane absorbers for polishing in antibody production, and by Alahari Arunakumari and colleagues from Medarex Inc., considering recent developments in non–Protein A purification processes for human monoclonal antibodies. Next, Guido Ströhlein and colleagues from the Swiss Federal Institute of Technology (ETH) Zurich describe a continuous, multicolumn purification system. We finish with an article by Rick Cooley of Dionex Corp. assessing the use of online liquid chromatography to achieve automation and control of process-scale columns.

These articles encapsulate the past, present, and possible future of process-scale chromatography in biopharmaceutical production. They are evidence of the progress that has been made in closing the performance gap between improvements in upstream production and downstream processing.

UWE GOTTSCHALK, PhD, is vice-president of purification technologies at Sartorius AG's biotechnology division, +49 551 308 2016, uwe.gottschalk@sartorius.com He is also a member of BioPharm International's editorial advisory board.