We are proud to call some of the pharma industry’s most talented engineers and scientists “our colleagues”.
One of them is Prof. Dr. Kurt Eyer, Lead Engineer – Process Bio at Pharmaplan Switzerland, who recently co-wrote a scientific essay published in the Biotechnology and Bioengineering (2020) journal issued by Wiley. Increasing purification performance is an omnipresent topic within pharmaceutical downstream processes. A new direction on how to improve purification processes is given in Kurt’s publication:
The paper outlines that Protein A capture chromatography is a critical unit operation in the clearance of host cell protein (HCP) impurities in monoclonal antibody (mAb) purification processes. Though one of the most effective purification steps, variable levels of protein impurities are often observed in the eluate.
The results shown demonstrate that optimization of the mAb purification process utilizing Protein A as the primary capture step depends primarily on being able to effectively clear DNA and associated complexes early in the process, rather than trying to incorporate HCP reduction at the harvest cell culture fluid. These results are consistent across three different biosimilar therapeutic mAbs expressed by the same Chinese hamster ovary (CHO) cell line.
Removing more impurities early in the process will lead to increased purification performance due to protection of the chromatography columns.
This will simplify the process by removing multiple types of impurities in a single process step, and this will lead to better process economics. Future processes could be simplified eg. by decreasing the column sizes, significant reduction in filter surface area for sterilizing filters, less polishing steps. Of course, this has still to be proven with other cell lines and for more processes, but the trials have shown a new direction of process intensification.
Congratulations to Kurt to your outstanding publication which has great potential to change the pharmaceutical mAb production and its process intensification in the future! We are proud having you on board!
If you are interested in reading the full essay, please visit: https://doi.org/10.1002/bit.27513
Source: Van de Velde J, Saller MJ, Eyer K, Voloshin A. Chromatographic clarification overcomes chromatin‐mediated hitch‐hiking interactions on Protein A capture column. Biotechnology and Bioengineering. 2020;1–9.
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