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Bioassays represent an essential step for the development of new drugs, in particular, according to regulatory requirement, they are performed to determine the biological activity or potency of a product, a critical quality attribute as explained in ICH Q6B.
Due to their complex nature, bioassays are one of the most challenging tests to perform. Indeed, to perform and develop consistent assays it is necessary to have a controlled environment, skilled analysts with a thorough understanding of cell physiology and a well-developed and characterized method; furthermore compared to animal assays are less time consuming, less costly and less variable.
- Bioassays are used for determination of biological activity (potency) of biopharmaceuticals -> all substances which are manufactured using bacteria or cells (biotechnology)
- Required as Quality Control (QC) test for all biologics
- Potency bioassay can be used as GMP QC test
- Validation of Bioassay is required for clinical phase III samples
Moreover, the possibility to build specific clients ad hoc bioassays is one of the most challenging issues in the creation and testing of new drugs product. During this live free webinar our bioassay experts will address the principal challenges in bioassay design.