Use of Quality by the Design for the Modelling of Chromatographic Separations

Abstract

A desired goal of the PAT framework is to design and develop well understood processes that will consistently ensure a predefined quality at the end of the manufacturing process.^{[ 1 ]} Achieving this goal will reduce the time and cost of process development and ensure development of robust processes that can handle variability and deliver a predefined quality as regards yield, purity and productivity within the defined design space. This communication will focus on a set of scientific principles supporting process understanding and process design of chromatographic separations.

Keywords:

• Association
• Isotherm
• Model
• Preparative chromatography
• Protein
• Quality by design

Notes

Invited paper

Manuscript 6496B