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Expert Statement: Ferdinand Biermann, Fraunhofer Institute for Production Technology IPT

The Transition to Digitalization in the Pharmaceutical Industry

06.09.2021 - ISPE and its members are developing the roadmap to introduce Industry 4.0, also called the Smart Factory, at the pharmaceutical industry as Pharma 4.0 – an operating model that is interconnected, meaning that the digital tools allow for a fully connected network to enable direct communication between all levels in an organization.

Despite the transformational potential of digitalization, the pharma industry has historically been slower than other sectors in adopting digital tools, such as cloud storage, artificial intelligence (AI), machine learning (ML), blockchain, and remote communication technologies, and in ­mak­ing associated changes in workplace culture and strategic priorities. Now, however, the Covid-19 pandemic may be accel­erating the pace of change.
What are the digitalization trends in the industry? What is the business case to develop and implement digital tools and digitalization strategies? And how can organizations introduce and use them?

CHEManager asked executives and industry experts to share their views on digitalization trends in the pharmaceutical industry and challenges on the way to realize the sector’s digital transformation. We proposed to discuss the following aspects:

  • What do you think are the key digitalization trends in the pharmaceutical industry?
  • What do you consider to be the most important benefits of digitalization in the pharmaceutical industry?
  • Is your company involved in system­atic, ongoing action to digitalize operations?
  • At present, digitalization in the pharmaceutical industry is immature. In your view, what are the biggest obstacles that need to be overcome in the digitalization of the sector?
  • How would you rate the digital maturity level of your company?

 

 

“Process chains can be organized
more agile through digitizationand networking.”

 

 

Ferdinand Biermann: Digitization and networking are the central development concepts of production in the sense of ‘Industrie 4.0’. For manufacturing pharmaceutical companies, these modernizations result in significant market advantages: One is that powerful systems for obtaining and evaluating process and product data in real time provide valuable information that can be used for optimization. Additionally, they facilitate compliance with regulatory requirements - from Good Manufacturing Practice (GMP) to EU directives on serialization and anti-counterfeiting.

Furthermore, process chains can be organized more agile through digitization and networking. This results in a new level of flexibility that prepares pharmaceutical manufacturers for the challenges of the personalized medicine of the future. The modernization and development of production processes and process chains according to ‘Industrie 4.0’ is a core competence of the Fraunhofer IPT: Together with our partners, we develop individual solution concepts for the establishment of new technologies as well as for networking and adaptive design of production in pharma companies.