Modern trends in downstream processing of biotherapeutics through continuous chromatography: The potential of Multicolumn Countercurrent Solvent Gradient Purification

https://doi.org/10.1016/j.trac.2020.116051Get rights and content

Highlights

  • Downstream processing bottleneck to production of biotherapeutics.

  • Multicolumn continuous chromatography alleviates yield/purity trade-off.

  • Multicolumn Countercurrent Solvent Gradient Purification ideal for biomolecules.

  • Model-based design needed for optimization of process operating conditions.

Abstract

Single-column (batch) preparative chromatography is the technique of choice for purification of biotherapeutics but it is often characterized by an intrinsic limitation in terms of yield-purity trade-off, especially for separations containing a larger number of product-related impurities. This drawback can be alleviated by employing multicolumn continuous chromatography. Among the different methods working in continuous mode, in this paper we will focus in particular on Multicolumn Countercurrent Solvent Gradient Purification (MCSGP) which has been specifically designed for challenging separations of target biomolecules from their product-related impurities. The improvements come from the automatic internal recycling of the impure fractions inside the chromatographic system, which results in an increased yield without compromising the purity of the pool. In this article, steps of the manufacturing process of biopharmaceuticals will be described, as well as the advantages of continuous chromatography over batch processes, by particularly focusing on MCSGP.

Keywords

Continuous chromatography
Preparative chromatography
Purification
Multicolumn platforms
Biopharmaceuticals
Biotherapeutics

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