Data-Driven Manufacturing Operations

Summary

A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Biopharmaceuticals may be produced from microbial cells, mammalian cell lines, or plant cell cultures in bioreactors. In the final stage of the (sterile) manufacture of such large molecules, the active pharmaceutical ingredient (or drug substance), excipients, and water must be amalgamated and transferred into the designated containers (i.e., vials or syringes). Despite the automation of the actual production processes (e.g., filling or visual inspection), numerous other processes such as reporting, planning, and troubleshooting are manual and time-consuming.

For instance, a plethora of data is generated in this setting, which can be utilized for decision support. This encompasses data from manufacturing instructions, deviation reports, electronic batch records, sensor and alarm data from the operational historian, or business data from the enterprise resource planning system.

The objective of this endeavour was to automate or digitalize these other manual processes and to leverage the available data to cultivate a culture of data-driven pharmaceutical manufacturing. This culminated, for instance, in the establishment of a digital hub.

Examples

Data Analytics

There are several data sets that can be used for pattern recognition, including sensor data from production equipment and entries in electronic batch records.

(Generative) Artificial Intelligence

A large amount of documentation is typically generated during the commercialisation of pharmaceuticals. This documentation can include manufacturing instructions, regulatory documents, and guidelines for operational excellence, to name a few examples. Generative artificial intelligence has the potential to make this knowledge more accessible. Additionally, in certain cases, rough drafts of documents can be created.