Progress in the use of biological assays during the development of biotechnology products.

The complexity of the structure and function of many biotechnology derived products necessitates a wide range of analytical procedures to adequately characterize the product. In-depth characterization is required for the assessment of several criteria vital to the success of product development such as consistency, purity, stability, and potency. More recently, the concern over the immunogenicity of biologics has increased the need to develop assays to detect neutralizing anti-product antibodies. Although many physicochemical tests are available to characterize the structure of a protein and detect the presence of contaminants, they provide little, if any, information regarding biological potency or the neutralizing capacity of antibody responses in immunogenicity studies. There is a continual need to refine biological assays to increase their accuracy and reproducibility, in particular to replace in vivo bioassays with appropriate in vitro assays. There have also been several recent technological developments that could lead to more rapid and reproducible bioassays.