This article explores the development of process chromatography.
Process chromatography was first applied to the removal of low
molecular weight solutes from whey by gel filtration about 50
years ago. An analytical method using size exclusion
chromatography was scaled up for insulin production in the
1970s, when ion exchange became a viable technology for the same
application. Ion exchange was adopted as the industry workhorse
as robust resins became available and formed the backbone of
chromatographic processing of blood plasma fractionation in
alternatives to and extensions of ethanol precipitation. Cost
restrictions kept affinity chromatography in the laboratory
until the production of MAbs made efficient immunoaffinity
indispensable in high purity coagulation factor production in
the 1980s. Since then, spurred on by the advent of
biotechnology, an extensive toolbox of chromatographic methods
has been developed, and a process chromatographic
capture–purify– polish regime is ubiquitous. Affinity capture of