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Considerations in upstream bioprocess monitoring and statistical data analysis in the context of process analytical technology and quality by design

Gerald Striedner & Karl Bayer

Economic and regulatory drivers tend to move the manufacturing of biopharmaceuticals from an empiricism-driven art to a science and engineering-based technology. Therefore, the US FDA started the process analytical technology and quality by design initiative to modernize risk-based regulation of quality. Industry implementation is encouraged by increased flexibility and knowledge-based approval procedures. In brief, the concept is based on advanced process monitoring and control, quality built in by design and the definition of the design space. Major obstacles in the translation of the process analytical technology concept are the complexity of biological systems and their limited online observability. To circumvent the lack of physiology-relevant online sensors and to improve process understanding either new online sensor devices are implemented, such as real-time analysis of volatile compounds, or multivariate statistical methods are employed to extract hidden information from acquired data sets, thereby enabling the prediction of non-measurable variables in real time.