ABSTRACT
When biological assays are used to support process development, clinical trials, and quality control of biotechnology products, it is essential to understand how medical requirements, degradation properties, and variation in the manufacturing process combine to impose performance requirements on the properties of the bioassay as an analytic method. This chapter illustrates this linkage and provides strategic methods to build assays (with best-practices for design and analysis), how to effectively improve assays using designed experiments, and how to quantify assay capabilities.
