Application of spectroscopic methods for monitoring of bioprocesses and the implications for the manufacture of biologics

Abstract

The ability to monitor and control bioreactor processes is an integral component to the implementation of Process Analytical Technology and Quality by Design principles. Desirable attributes of monitoring methods include the ability to monitor multiple analytes in real time with little to no sample processing. Spectroscopic methods fit these criteria and significant advancements in their application have been made. However, implementation of these systems has been hampered by their complexity. Here, we present an overview of near IR, mid-IR, Raman and fluorescence spectroscopy technologies, and the steps taken to enable their implementation as effective bioprocess monitoring tools. Specific applications for monitoring of microbial and mammalian cell bioreactors, and screening and classification of raw materials are discussed.