Digitalization and Bioprocessing: Promises and Challenges

Research output: Chapter in book/report/conference proceedingContribution to book/anthologyResearchpeer review

Authors

External Research Organisations

  • RWTH Aachen University
  • Forschungszentrum Jülich
  • Sanofi-Aventis Deutschland GmbH
  • Colorado State University
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Details

Original languageEnglish
Title of host publicationDigital Twins
Subtitle of host publicationTools and Concepts for Smart Biomanufacturing
EditorsChristoph Herwig, Ralf Pörtner, Johannes Möller
Pages57-69
Number of pages13
Volume176
Edition1
ISBN (electronic)9783030716608
Publication statusPublished - 1 Sept 2020

Publication series

NameAdvances in biochemical engineering/biotechnology
ISSN (Print)0724-6145

Abstract

The production of pharmaceuticals, industrial chemicals, and food ingredients from biotechnological processes is a vast and rapidly growing industry. While advances in synthetic biology and metabolic engineering have made it possible to produce thousands of new molecules from cells, few of these molecules have reached the market. The traditional methods of strain and bioprocess development that transform laboratory results to industrial processes are slow and use computers and networks only for data acquisition and storage. Digitalization, machine learning (ML), and artificial intelligence (AI) methods are transforming many fields - how can they be applied to bioprocessing to overcome current bottlenecks? What are the challenges, especially for regulatory issues, in the production of biopharmaceuticals? This chapter begins with a discussion of the current challenges for strain and bioprocess development and then considers how digitalization can be used to approach these tasks in completely new ways. Finally, regulatory considerations are addressed, with the goal of incorporating these issues from the outset as new digitalization methods are created.

Keywords

    Digital twins, Digitalization, FDA, QbD, Regulatory considerations

ASJC Scopus subject areas

Cite this

Digitalization and Bioprocessing: Promises and Challenges . / Scheper, Thomas; Beutel, Sascha; McGuinness, Nina et al.
Digital Twins: Tools and Concepts for Smart Biomanufacturing. ed. / Christoph Herwig; Ralf Pörtner; Johannes Möller. Vol. 176 1. ed. 2020. p. 57-69 (Advances in biochemical engineering/biotechnology).

Research output: Chapter in book/report/conference proceedingContribution to book/anthologyResearchpeer review

Scheper, T, Beutel, S, McGuinness, N, Heiden, S, Oldiges, M, Lammers, F & Reardon, KF 2020, Digitalization and Bioprocessing: Promises and Challenges . in C Herwig, R Pörtner & J Möller (eds), Digital Twins: Tools and Concepts for Smart Biomanufacturing. 1 edn, vol. 176, Advances in biochemical engineering/biotechnology, pp. 57-69. https://doi.org/10.1007/10_2020_139
Scheper, T., Beutel, S., McGuinness, N., Heiden, S., Oldiges, M., Lammers, F., & Reardon, K. F. (2020). Digitalization and Bioprocessing: Promises and Challenges . In C. Herwig, R. Pörtner, & J. Möller (Eds.), Digital Twins: Tools and Concepts for Smart Biomanufacturing (1 ed., Vol. 176, pp. 57-69). (Advances in biochemical engineering/biotechnology). https://doi.org/10.1007/10_2020_139
Scheper T, Beutel S, McGuinness N, Heiden S, Oldiges M, Lammers F et al. Digitalization and Bioprocessing: Promises and Challenges . In Herwig C, Pörtner R, Möller J, editors, Digital Twins: Tools and Concepts for Smart Biomanufacturing. 1 ed. Vol. 176. 2020. p. 57-69. (Advances in biochemical engineering/biotechnology). doi: 10.1007/10_2020_139
Scheper, Thomas ; Beutel, Sascha ; McGuinness, Nina et al. / Digitalization and Bioprocessing : Promises and Challenges . Digital Twins: Tools and Concepts for Smart Biomanufacturing. editor / Christoph Herwig ; Ralf Pörtner ; Johannes Möller. Vol. 176 1. ed. 2020. pp. 57-69 (Advances in biochemical engineering/biotechnology).
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