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Biotechnology Services
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Bioassay and Biopotency Determinations
Drawing on in-house expertise with animal models, cell biology, molecular biology, statistics and protein analytical chemistry, Covance offers a dedicated service for the measurement of biological activity for a variety of therapeutics under development. However, because biological potency assays are as unique as the therapeutics being developed, the requirements of the client are addressed through consultation on an individual basis. This custom service allows the assay to be developed, validated and subsequently used in a manner compliant with applicable regulations. The service segments include:
- Batch release testing
- Product characterization
- Product stability assessment
- Candidate selection
- Metabolite activity
- Neutralizing antibody activity.
The Biological Potency Assessment service has a wide range of experience and includes the following types of testing:
- Cell proliferation/inhibition using 3H-thymidine, 3H-Leucine or dye incorporation endpoints
- Receptor binding — use of cell types expressing specific receptors
- Radiolabelled compound influx/efflux
- Receptor mediated response assays — analysis of markers in culture media
- Animal models
- Cellular expression using flow cytometry
- Chromogenic endpoint activity assays
- Statistical analysis using Pharmacopoeial methods including parallelism determination.
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