Feature Article: Building Process Control Into Chromatographic Purification Of Viruses, Part 2

By Denise Gavin and Pete Gagnon

Purification represents a nexus in the manufacture of biopharmaceutical products: a point at which all manufacturing components and their individual variations converge. This challenges process developers to configure the components in ways that either cancel or minimize the potentially negative impacts of their respective variations. This is fully as important as achieving a specified level of purity because this is where it is established that a process will reproducibly yield high-quality product. One hallmark of chromatography methods is their ability to support this aspect of process development.

The more fundamental role of purification is to remove contaminants. Numerous chromatography methods have been reported for virus purification, including affinity (1–4), size exclusion (4–8), ion exchange (6–12), hydrophobic interaction (7, 8), and hydroxyapatite chromatography (12). Many studies comment that even single-step chromatography procedures achieve better purity than multistep density-gradient–based methods.

Reprinted with permission from BioProcess International 4(11):28-34 (December 2006)

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