Bioassays provide valuable information in developing and assessing biological therapeutic products, especially in concentration, purity, or biological activity determination. For therapeutic antibodies and proteins, one of the most promising bioactive molecules for novel drug discovery, researchers need more instructive data to evaluate batch-to-batch consistency and stability when designing, generating, and manufacturing these biological therapeutic products. Bioassays, undoubtedly, are the best solution to obtain valid data at all stages of developing biological products, from early target selection work to the final quality control of finished products.

This review describes diverse bioassay strategies for different research intentions and sample types as well as statistical analysis methods, which reads in part as follows:

1. 12+ Bioassays Protocols for Antibody and Protein Development
2. A Bunch of Analytical Methods for Bioassay Results
3. Quality Control Strategies for IND Regulatory Compliance
4. Custom Solutions to Antibody Bioassays