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Digitalization and Bioprocessing: Promises and Challenges.

Thomas Scheper1, Sascha Beutel2, Nina McGuinness2

  • 1Institute of Technical Chemistry, Leibniz University Hannover, Hannover, Germany. Scheper@iftc.uni-hannover.de.

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Summary
This summary is machine-generated.

Digitalization, machine learning (ML), and artificial intelligence (AI) can accelerate biopharmaceutical production. Integrating these technologies and addressing regulatory issues early can overcome bottlenecks in industrial bioprocessing.

Keywords:
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Area of Science:

  • Biotechnology and bioprocessing
  • Industrial microbiology
  • Pharmaceutical manufacturing

Background:

  • The biotechnology industry produces pharmaceuticals, chemicals, and food ingredients, but few new molecules reach the market.
  • Traditional bioprocess development is slow, with limited computational integration.
  • Current methods struggle to scale laboratory discoveries to industrial production.

Purpose of the Study:

  • To explore the application of digitalization, ML, and AI in bioprocessing.
  • To identify and address bottlenecks in strain and bioprocess development.
  • To integrate regulatory considerations into novel digitalization strategies for biopharmaceutical production.

Main Methods:

  • Review of current challenges in strain and bioprocess development.
  • Exploration of digitalization, ML, and AI applications for bioprocessing.
  • Analysis of regulatory issues in biopharmaceutical production.

Main Results:

  • Digitalization offers novel approaches to accelerate bioprocess development.
  • ML and AI can overcome traditional bottlenecks in scaling up bioproduction.
  • Early integration of regulatory affairs is crucial for successful biopharmaceutical manufacturing.

Conclusions:

  • Implementing digitalization, ML, and AI is key to advancing biopharmaceutical production.
  • Addressing regulatory challenges proactively ensures efficient market entry.
  • A holistic approach combining technological innovation and regulatory foresight is essential.