ABSTRACT
In traditional monoclonal antibody (mAb) manufacturing, the first purification process step of crude harvest (obtained from cell culture) is Protein-A Chromatography. This expensive column resin is often under-utilized for clinical or orphan
drug products since the chromatography columns are dedicated per product. In this paper, three innovative
considerations for more efficient use of Protein-A chromatography columns are discussed:
• Evaluating possibilities of extending the lifetime of a Protein-A chromatography column by approaching cleaning as a
process using identified Critical Process Parameters (CPPs) and Critical Material Attributes (CMAs) in a computerized
Computer Fluid Dynamics (CFD) model,
• Re-evaluating the sequence of the purification chromatography steps of monoclonal antibodies manufacturing by
incorporating the Protein-A column as the last chromatography purification step which results in benefits from a cost,
cleanability and sustainability perspective, and
• Exploring the possibilities of sharing a Protein-A chromatography column with additional mAb products and steps for
future application. These three considerations can potentially lead to a more efficient use of the Protein-A chromatography
column in mAb manufacturing while reducing the costs of development and manufacturing.
