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Monitoring Host Cell DNA and Protein Levels

Host cell DNA and protein contamination within biopharmaceutical products are strictly limited under the European Medicines Agency (EMA) guidelines.

Background

Biopharmaceuticals are produced within living cells that are in a constant flux between replication and apoptosis. Hose cell DNA and protein contamination within biopharmaceutical products are strictly limited under the European Medicines Agency (EMA) guidelines.

A customer was producing a recombinant monoclonal antibody from chinese hamster ovary cells (CHO) within a 50 L bioreactor. The company strategy was to scale up production to 1000 L bioreactor.


Approach and Results

RSSL were engaged to monitor host cell DNA and protein levels during production and after antibody product purification. This was monitored quantitatively by real-time PCR and enzyme linked immunosorbent assay (ELISA) respectively.

Although the host cell DNA and protein levels remained within acceptable levels after scale-up, in vitro studies identified reduced antibody efficacy. We established by SDS-PAGE the reduced potency was due to protein-G contamination from the purification process. An alternative purification strategy was suggested to overcome protein-G contamination.

The improved purification step resolved antibody efficacy

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