Process tech data standards would help biopharma digitize, Siemans study

Drug makers need data standards to realize the full benefits of digital manufacturing tech, according to new analysis.

The research – by German technology conglomerate Siemens – focused on how digital systems are reshaping the production of medicines with the authors quizzing executives from 31 firms in the UK and Ireland about changes over the past two years.

And the key finding is that biopharmaceutical firms need data standards according to the authors, who cite integration as a major challenge for companies seeking to digitize manufacturing operations.

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“Single-use biopharmaceutical manufacturing equipment, and the growing number of disparate process technologies, urgently need common standards to ensure the interoperability that manufacturers are increasingly demanding from suppliers.

“Individual pieces of equipment generate important data about the quality of product being manufactured, but unless they are operating to common standards, insights cannot be easily unlocked, nor the full value of digitalization be leveraged,” the authors write.

Work is being done to try and address the lack of data standards. The authors cite efforts by the International Society for Pharmaceutical Engineering (ISPE) and Biophorum, as examples. However, they suggest more needs to be done.

Digital modelling

Data standards would help accelerate biopharma’s move towards digital manufacturing in other ways according to the Siemens team, who predict the use of “digital twins” would increase if process measurements were more uniform.

For the uninitiated, a digital twin is a computer model of a biopharmaceutical manufacturing process. They can be used to fine tune processes during development and even to control established manufacturing operations.

And, according to the authors, “Data standards are also critical to introducing the Digital Twin concept. The virtual and augmented reality which a Digital Twin enables is being used in the production environment to speed up bioreactor set-up, test optimization possibilities, enable proof of concept and guided workflows, and implement improved training and service/maintenance.”


Agencies that oversee the drug industry would also see some benefit from data standardization. The Siemens team suggest that standards would help manufacturers provide organizations like the US FDA and the EMA with a more detailed picture of production activities.

“Visibility of digital data flows in all aspects of biopharma – “from concept to clinic” – is also contributing to regulatory supervision, reducing the burden on biopharma companies, and at the same time increasing hard-pressed regulators’ and notified bodies’ ability to scrutinize the industry,” the authors write.