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Big Data, Pharma 4.0 and Process Modeling

By Wayne Levin, Predictum and Jana Spes, Boston Biomedical

A lot has been written about Industry 4.0, including that it will create a “smart factory” and make systems more flexible to enable mass customization of manufactured products; points resonating with pharmaceutical industry trends toward increased efficiency and personalized medicine. In these systems, information is shared through a cloud-based system to allow key data to be used for the quality decision, continuous improvement with potentially a goal to go beyond compliance.

This paper discusses how to improve process knowledge and set foundation for big data use. The methods described can be extended to any portfolio with complex manufacturing processes that have commercialized over the last several decades.

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