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Background <p>The Pharma 4.0 digitalization revolution is transforming pharmaceutical manufacturing and production by integrating advanced technologies to reduce time and cost while enhancing efficiency. This review explores the key trends in digitalization, emphasizing the integration of big data, artificial intelligence, digital twins, continuous production, process analytical technology, and quality by design.</p> Area covered <p>While the pharmaceutical industry remains highly regulated, cutting-edge technologies from the fourth industrial revolution are already being applied. This review presents examples of these technologies and introduces hyperconnected systems in which these technologies are integrated. Subsequently, this review highlights the future of digital pharmaceutical technology by discussing the synergistic benefits of such integration.</p> Expert opinion <p>Unlike prior reviews that discuss these technologies individually, this review comprehensively examines their integration into a hyperconnected ecosystem, highlighting advantages and real-world case studies. Furthermore, this review underscores the transformative potential of digitalization for pharmaceutical manufacturing by defining key concepts, presenting examples, and analyzing trends. These insights aim to inspire broader adoption of hyperconnected digital technologies, showcasing their capability to drive innovation and efficiency.</p>

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Recent trends in continuous manufacturing and digitalization in pharmaceutical process development and manufacturing

  • 期刊论文

  • 发表日期：

    2025年2月7日

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  • Seong-June Gong,
  • Ha Rin Kim,
  • Young-Joon Park,
  • Joo-Eun Kim

摘要

Background

The Pharma 4.0 digitalization revolution is transforming pharmaceutical manufacturing and production by integrating advanced technologies to reduce time and cost while enhancing efficiency. This review explores the key trends in digitalization, emphasizing the integration of big data, artificial intelligence, digital twins, continuous production, process analytical technology, and quality by design.

Area covered

While the pharmaceutical industry remains highly regulated, cutting-edge technologies from the fourth industrial revolution are already being applied. This review presents examples of these technologies and introduces hyperconnected systems in which these technologies are integrated. Subsequently, this review highlights the future of digital pharmaceutical technology by discussing the synergistic benefits of such integration.

Expert opinion

Unlike prior reviews that discuss these technologies individually, this review comprehensively examines their integration into a hyperconnected ecosystem, highlighting advantages and real-world case studies. Furthermore, this review underscores the transformative potential of digitalization for pharmaceutical manufacturing by defining key concepts, presenting examples, and analyzing trends. These insights aim to inspire broader adoption of hyperconnected digital technologies, showcasing their capability to drive innovation and efficiency.