Pharmaceutical Industry 4.0

Dear Colleagues,

The pharmaceutical industry is under a major change in light of specific regulatory, scientific, and technological advancements. Following a long period of inaction, the pharmaceutical industry faced the first wave of change mainly originating from the regulatory authorities. The FDA’s new quality initiatives started during the 1990s and focused on process engineering, introduced novel approaches for Pharma such as systems thinking in GMPs, quality by design, pharmaceutical quality system, quality risk management, continuous manufacturing, etc. This wave shaped a totally new regulatory framework, which significantly disrupted Pharma’s old culture regarding, among others, its outdated manufacturing methodologies and empirical development practices. Consequently, and more recently, the Industry 4.0 wave of change impacted deeper the traditional ways the Pharma Industry was adopting in its supply chain, research, manufacturing, and business practices. AI/ML, Big Data, precision medicine, digitalization, smart factories, 3D printing, just to name a few, require totally new knowledge and skills for the Pharma’s work force. This Special Issue will present in detail all these technological breakthroughs, which when taken as a whole, will eventually reflect the pillars of the Pharmaceutical Industry 4.0 paradigm which is under way.

Assoc. Prof. & Head Dimitrios M. Rekkas
Dr. Panorios Benardos
Guest Editors

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• Pharma industry 4.0
• Bioprocess technology & engineering
• The smart factory
• Digital therapeutics
• AI and machine learning in the pharmaceutical industry
• The new manufacturing paradigm within the QbD framework
• Technology or knowledge transfer?
• The new era of precision medicine and e-clinical trials
• Digital twins technology
• 3D printing
• The new architecture of the pharmaceutical supply chains