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ViruSure - Monoclonal Antibodies (mAbs)
Monoclonal antibodies (mAbs) are the largest segment of marketed biopharmaceuticals today. Whether you are developing an originator molecule or a biosimilar, your antibody derived from a recombinant cell line such as Chinese Hamster Ovary (CHO) must meet regulatory standards for the absence of virus and other pathogens.
We have been a trusted resource for GMP cell banking services as well as virus and prion clearance studies and adventitious agent testing for mAbs for almost two decades.
As all mAbs are derived from eukaryotic cells, there is risk of pathogen contamination from the cell itself and from the production process. The clearance or inactivation of potential contaminants via the purification process must be assured through clearance studies.
In addition, it is critical to characterize and control the cell banks used for expression of the antibodies.