Monoclonal Antibodies

Essential therapeutics in today’s treatment regimen

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.

ViruSure offers the following services
for producers of mAbs:

Process Validation Studies
Pathogen Safety Testing + Cell Characterization
Genetic Stability
Cell Banking + Storage
In Vivo Tumorigenicity + Oncogenicity Studies
Potency Studies

In Vivo Potency Studies


Let's Talk About Your Monoclonal Antibodies

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