Conclusion
Although the biopharma industry is highly regulated, there are many
opportunities to develop better and more robust processes. This is also
encouraged by health authorities with the various guidelines that have
been adopted in the past, such as PAT, QbD, Continuous Manufacturing and
Real-time Release. All the elements for technical implementation are in
place and there is acceptance by the authorities. There is a perception
that real-time monitoring is difficult to implement and requires a lot
of change. It is possible to integrate real-time monitoring gradually
and it should be considered from a soft sensor perspective. This concept
has been successfully implemented in other industries. It required
relatively simple model training and the use of established statistical
tools such as multivariate statistics or neural networks. Such
approaches have been practiced for decades and are known as chemometrics
when multiple analytical methods were required to measure a particular
analytical attribute. A soft sensor could also be described with
predictive chemometrics. A fully controlled and automated process would
also help reduce drug shortages, improve process economics, and reduce
the environmental footprint.