Advances in downstream processing of biologics - Spectroscopy: An emerging process analytical technology

- Review of current approaches to PAT for proteins in DSP.
- The review focuses on spectroscopy as an emerging tool for PAT.
- An introduction and overview to central chemometric tools for PAT is given.

Process analytical technologies (PAT) for the manufacturing of biologics have drawn increased interest in the last decade. Besides being encouraged by the Food and Drug Administration's (FDA's) PAT initiative, PAT promises to improve process understanding, reduce overall production costs and help to implement continuous manufacturing. This article focuses on spectroscopic tools for PAT in downstream processing (DSP). Recent advances and future perspectives will be reviewed. In order to exploit the full potential of gathered data, chemometric tools are widely used for the evaluation of complex spectroscopic information. Thus, an introduction into the field will be given.