STEPHEN M. WING
EMD Millipore, Bedford, USA, Life Science Business of Merck KGaA, Darmstadt, Germany

Abstract

Various digital technologies are currently available to help biopharmaceutical and pharmaceutical manufacturers drive significant process improvements. There are numerous areas where process automation and simplification can be enabled using electronic data (eData) from key raw material suppliers. This article describes some current use cases in which the manufacturer’s analytical capabilities are enhanced using a standard eData platform, and also explores future opportunities to optimize other critical parts of the production process including logistics-related applications.

DATA ENABLES PHARMA 4.0
With the advancement of Pharma 4.0, there is the potential to implement significant business improvements using digital tools and capabilities. The availability of technologies, such as cloud-based platforms, artificial intelligence (AI), machine learning (ML), advanced process analytics, etc., enables drug manufacturers to better understand, monitor, and control their production processes. However, these technologies are simply tools and a thorough understanding of specific applications and use cases is an absolute necessity in selecting and implementing the right technologies for a particular situation.

THE RIGHT DATA AT THE RIGHT TIME
The common denominator for effective application of Pharma 4.0 technologies is having access to the critical data when it is needed for the specific process. If, in order to drive time sensitive actions or process control adjustments, an application requires real-time access to the data, then the system architecture and data flow needs to be set-up to support this access. However, if the data is being used retroactively, such as in trending analysis ap ...