摘要：The antibody manufacturing process consists of the cell culture process using animal cells and the purification process including several chromatography steps and filtration steps. The purification process is important to obtain high quality bio-pharmaceutical products by removing impurities, and measurement of antibody concentrations is a fundamental and essential factor to control the manufacturing process and to confirm the yield of each purification step. Here we introduce the optical rotation method as a resolution for measuring antibody concentrations in the manufacturing process. Feasibility evaluation showed that optical rotation is applicable for measuring a wide range of antibody concentrations even in cell culture supernatants containing various contaminants. In addition, as examples of application to the process analytical technology, we show the possibility of the optical rotation method in the continuous cell culture and chromatography process, and the tangential flow filtration concentration process.
