Abstract
AbstractThe separation of one weakly and one strongly binding impurity from a therapeutic protein by ion‐exchange chromatography was studied with a mechanistic model. The effect of disturbances in eight potentially critical process parameters on two critical quality attributes was evaluated. It was found that the outgoing concentration of the weakly binding impurity was only affected by the ingoing concentration of this impurity, while the target product purity was affected by the amounts of buffer and acid used to prepare the elution buffers and the protein concentration and purity of the feed. Full factor analysis of these parameters showed that there were interaction effects between the parameters due to the pH dependence of the chromatographic separation. Sampling‐based robustness analysis estimated the probability of batch failure to be above 1 %. The model improved the analysis as it was possible to study the effects of more process parameters and their interactions than would have been possible in an experimental study.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.