Accelerating Biologics Manufacturing by Modeling or: Is Approval under the QbD and PAT Approaches Demanded by Authorities Acceptable without a Digital-Twin?

Accelerating Biologics Manufacturing by Modeling or: Is Approval under the QbD and PAT Approaches Demanded by Authorities Acceptable without a Digital-Twin?

Innovative biologics, including cell therapeutics, virus-like particles, exosomes, recombinant proteins, and peptides, seem likely to substitute monoclonal antibodies as the main therapeutic entities in manufacturing over the next decades. This molecular variety causes a growing need for a general c...

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Bibliographic Details
Main Authors: Steffen Zobel-Roos, Axel Schmidt, Fabian Mestmäcker, Mourad Mouellef, Maximilian Huter, Lukas Uhlenbrock, Martin Kornecki, Lara Lohmann, Reinhard Ditz, Jochen Strube
Format: Article
Language:English
Published: MDPI AG 2019-02-01
Series:Processes
Subjects:
biologics
manufacturing
modeling
continuous bioprocessing
modular plants
process intensification
sustainability
Online Access:https://www.mdpi.com/2227-9717/7/2/94

Internet

https://www.mdpi.com/2227-9717/7/2/94

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