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Purifying biopharmaceuticals: knowledge-based chromatographic process development

Paper ID Volume ID Publish Year Pages File Format Full-Text
37158 45317 2014 11 PDF Available
Title
Purifying biopharmaceuticals: knowledge-based chromatographic process development
Abstract

•We review process development approaches for the chromatographic purification of proteins.•We present experimental methods for the determination of protein properties and interactions.•Methods are connected to mathematical models for performance prediction and optimisation.•A modular process development concept is introduced.

The purification of biopharmaceuticals is commonly considered the bottleneck of the manufacturing process. Increasing product diversity, along with growing regulatory and economic constraints raise the need to adopt new rational, systematic, and generally applicable process development strategies. Liquid chromatography is the key step in most purification processes and a well-understood unit operation, yet this understanding is still rarely effectively utilized during process development. Knowledge of the composition of the mixture, the molecular properties of the solutes and how they interact with the resins are required to rationalise the design choices. Here, we provide an overview of the advances in the determination and measurement of these properties and interactions, and outline their use throughout the different stages of downstream process development.

Keywords
process development; chromatography; high-throughput; host cell proteins; mathematical modelling
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Publisher
Database: Elsevier - ScienceDirect
Journal: - Volume 32, Issue 4, April 2014, Pages 210–220
Authors
, ,
Subjects
Physical Sciences and Engineering Chemical Engineering Bioengineering
Get Full-Text Now
Don't Miss Today's Special Offer
Price was $35.95
You save - $31
Price after discount Only $4.95
100% Money Back Guarantee
Full-text PDF Download
Online Support
Any Questions? feel free to contact us