Application of AQbD to cIEF of Protein Biopharmaceuticals

Jong Won Kim
2019 Biomedical Journal of Scientific & Technical Research  
Recombinant monoclonal antibodies (mAbs) have become a wide range of relevant for the treatment of various diseases. Because of their inherent complexity structure and safety reasons, it needs to control all the processes for achieving a consistent product that is absolutely necessary. In short communication shows that the importance of analytical quality by design of biopharmaceutical agents and the current analytical methods for mAbs will be discussed.
doi:10.26717/bjstr.2019.22.003782 fatcat:626mxvbisvbtxdvzjtnbd2leaq