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
mAbs

Virus Clearance Studies

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Prion Clearance Studies

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Pathogen Safety Testing + Cell Characterization

Sterility + Mycoplasma Testing

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In Vitro Safety Studies

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Molecular Tests (e.g. qPCR, PERT)

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TEM

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In Vivo Safety Studies

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GMP Lot Release (Bulk Harvest) Testing

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Identity

Identity testing via qPCR

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Genetic Stability

Gene Copy Number

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Genetic Sequencing

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Cell Banking + Storage

GMP Cell Banking

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GMP Cell Storage

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In Vivo Tumorigenicity + Oncogenicity Studies

In Vivo Tumorigenicity + Oncogenicity Studies

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Potency Studies

In Vitro Potency Studies

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In Vivo Potency Studies

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Consultancy

Consultancy + Risk Assessments

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Let's Talk About Your Monoclonal Antibodies

Tell us about your inquiry and we'll be in touch.