We are proud to call some of the most talented scientists and engineers in the pharmaceutical industry “our colleagues”. One of them is Prof. Dr. Kurt Eyer, Lead Engineer – Process Bio at Pharmaplan Switzerland, who recently co-authored a scientific essay that was published in the journal Biotechnology and Bioengineering (Wiley-Verlag 2020). Increasing cleaning performance is a ubiquitous topic in pharmaceutical downstream processes. A new direction to improve purification processes is shown in Kurt’s paper.
His article shows that affinity chromatography (protein A step) is a critical step in host cell protein (HCP) clearance -Contaminations in purification processes with monoclonal antibodies (mAb). Although this is one of the most effective purification steps, different concentrations of protein contaminants are often observed in the eluate.
The results show that optimization of the mAb purification process using Protein A as the primary capture step depends primarily on being able to effectively deplete DNA and associated complexes early in the process rather than trying to incorporate HCP reduction directly at the harvest step. These results could be confirmed with three different therapeutic mAbs expressed by the same CHO (Chinese Hamster Ovary) cell line.
Removing more contaminants early in the process ultimately results in the protection of the chromatography columns an increased purification performance.