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Digital Twins in Biomanufacturing.

Steffen Zobel-Roos1, Axel Schmidt1, Lukas Uhlenbrock1

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Summary
This summary is machine-generated.

Process modelling creates digital twins for manufacturing, supporting the entire workflow from development to production. This key digitalization tool offers cost-efficient benefits for the chemical-pharmaceutical industries.

Keywords:
Chemical-pharmaceutical industryDigital twinDigitalizationIndustry 4.0Process modelling

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Area of Science:

  • Chemical Engineering
  • Biotechnology
  • Pharmaceutical Manufacturing

Background:

  • Process modelling is an established method for creating digital twins of manufacturing operations using numerically solved models.
  • It supports the workflow across process development, piloting, engineering, and manufacturing stages.
  • Applications span botanicals and biologics, from plant extracts to complex molecules like mAbs, proteins, and peptides.

Purpose of the Study:

  • To discuss the benefits of establishing process modelling, either in-house or through cooperation.
  • To demonstrate the broad applicability of process modelling in diverse manufacturing sectors.
  • To highlight its role in integrating Quality-by-Design approaches and achieving cost-efficient digitalization.

Main Methods:

  • Utilizing numerically solved process models to generate digital twins.
  • Implementing efficient laboratory-scale experiments to determine case-specific physical properties for model parameters.
  • Integrating Quality-by-Design principles into predictive modelling procedures.

Main Results:

  • Process models are consistent and available for simulating whole processes.
  • Physical properties are determined via laboratory experiments due to the lack of comprehensive databases for biologics and botanicals.
  • Models are proven valid and predictive, meeting regulatory requirements.

Conclusions:

  • Process modelling provides immediate economic benefits from its initial application.
  • It is a crucial enabling technology for cost-efficient digitalization in the chemical-pharmaceutical industries.
  • The method is broadly applicable across various manufacturing processes involving complex molecules.