Capillary electrophoresis in the pharmaceutical and biotech industry

Capillary Electrophoresis (CE) has led a turbulent life in the pharmaceutical industry. Application of the CE techniques have continuously been increasing, but after the initial enthusiastic phase and fast adaptation, there was a decline in use at the start of the 21st century for small molecules. In this chapter the implementation and use of the CE applications in the pharmaceutical and biotechnology industry in the early twenty-first century are discussed. The requirements for CE to become a well-established technique for the analysis of therapeutic proteins are discussed as they also set the requirements for further development. Relevant old and new applications in industry illustrate the versatility of use of the CE techniques in industry. The application of Analytical Quality by Design (AQbD) on capillary electrophoresis method development, validation, implementation, and life cycle management is reviewed. The chapter ends with expectations of and hopes for the future use of the CE techniques. If the CE community keeps sharing good practice and good applications, CE will have a bright future in the pharmaceutical and biotech industry.