In Vitro Potency Studies

Cell-based methods to demonstrate the potency of biopharmaceutical products

The potency of a biopharmaceutical product is key for batch release and for biosimilar comparability assessment.

ViruSure can support you to develop and validate a customized cell-based potency assay to measure the biological activity of your biopharmaceutical product. Potency assays are available for a wide range of products such as antibodies, cytokines, hormones and vaccines.

Potency Assays on Biopharmaceutical Products

Potency Assays

Anti-viral assays (AVA)

Cell proliferation assays

Antibody-dependent cellular cytotoxicity assays (ADCC)

Complement-dependent cytotoxicity assays (CDC)

Reporter gene assays

MHC-I up-regulation assays

Induced lymphocyte assays (ILA)

Human Artificial Lymph Node (HuALN) model

Dendritic cell (DC) assays

T cell assays

Cytotoxicity and apoptosis assays

Cell cycle monitoring

Target specific CBAs

The use of animals for in vivo potency assays is diminishing, given disadvantages associated with cost, low throughput, practical, and especially ethical considerations.

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Let's Talk About Your In Vitro Potency Studies

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