Bioprocessing in the Digital Age: The Role of Process Models

Author:

Narayanan Harini1ORCID,Luna Martin F.1,Stosch Moritz2,Cruz Bournazou Mariano Nicolas13,Polotti Gianmarco3,Morbidelli Massimo13,Butté Alessandro13,Sokolov Michael13

Affiliation:

1. Institute for Chemical and Bioengineering ETHZ Zurich Switzerland

2. Technical R&DGSK Vaccines 1330 Rixensart Belgium

3. DataHow AGc/o ETH ZurichHCI, F137Vladimir‐Prelog‐Weg 1 8093 Zurich Switzerland

Publisher

Wiley

Subject

Molecular Medicine,Applied Microbiology and Biotechnology,General Medicine

Reference151 articles.

1. U.S. Food and Drug Administration Pharmaceutical CGMPs for the 21st Century—A Risk Based Approach; Final Report; U.S. Food and Drug Administration: Silver Spring MD 2004.

2. European Medicines Agency Guideline on Process Validation for the Manufacture of Biotechnology‐Derived Active Substances and Data to be Provided in the Regulatory Submission 2016 44 4.

3. Multivariate PAT solutions for biopharmaceutical cultivation: current progress and limitations

4. Assessment of Recent Process Analytical Technology (PAT) Trends: A Multiauthor Review

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