Bioassay testing or biological assay/screening is any qualitative or quantitative analysis of a substances that uses a living system, such as an intact cell, as a component.
Bioassay test services are most often employed to determine the concentration or purity of substances including vitamin, hormone, or plant growth factor by measuring their effect on tissue, cells, enzymes, or receptors. The general approach involves measuring the biological response of the live material at several doses, to understand the dose-response relation.
As such, the advantage of the bioassay testing procedure is that it can help determine both the concentration and potency of a sample, which is necessary for regulatory submission and lot release testing of biopharmaceutical products.
Method Development
Method Transfer
Method Optimization
ICH-Compliant Method Validation
Lot Release Testing For Drug Substances
Stability Testing
Comparability Testing Between Innovator and Follow-On Biologic
Accelerated Stress Condition Testing
Established Pharmacopeial Methods
We never let a specialized or demanding bioassay requirement stall our customers’ speed of innovation, and work scientist to scientist to solve even the most challenging bioanalytical assay needs with responsive service and seasoned expertise.
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