Small scale model justification: An industry position paper

Broadcast date

Wed, May 18, 2022

 

Presented by

    Robert G. Luo - GlaxoSmithKline

 

Quick Description

Presenting current understanding on how to successfully qualify an appropriate and applicable SSM, including design, execution, data analysis and justification of results.

Supported by
Masahiro Kokubo, Research Scientist.
Nobuyoshi Morigaki, Senior Scientist, Downstream Process Development.
Shunsuke Izaki, Research Scientist (downstream).
Kyowa Kirin Co Ltd

Details

Presenting current understanding on how to successfully qualify an appropriate and applicable small-scale model (SSM), including design, execution, data analysis and justification of results.

SSMs are a useful tool in biopharmaceutical process development. Design of the models requires careful choice of scaling parameters to best match large-scale outputs. Qualification of the models proves that they generate comparable performance and quality attributes, justifying their use to address regulatory expectations. Qualification is performed using statistical comparison to large-scale run data. A variety of statistical methods can be used for qualification with appropriate justification.

Speakers

Robert G. Luo

Scientific Director, BioPharm Development Process Group

GlaxoSmithKline