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Toward biotherapeutic product real-time quality monitoring

Lookup NU author(s): Mr. Guerra Guerra, Dr Moritz von Stosch, Professor Jarka Glassey


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© 2019, © 2019 Informa UK Limited, trading as Taylor & Francis Group.Biotherapeutics, such as those derived from monoclonal antibodies (mAbs), are industrially produced in controlled multiunit operation bioprocesses. Each unit operation contributes to the final characteristics of the bioproduct. The complexity of the bioprocesses, the cellular machinery, and the bioproduct molecules, typically leads to inherent heterogeneity and variability of the final critical quality attributes (CQAs). In order to improve process control and increase product quality assurance, online and real-time monitoring of product CQAs is most relevant. In this review, the recent advances in CQAs monitoring of biotherapeutic drugs, with emphasis on mAbs, and throughout, the different bioprocess unit operations are reviewed. Recent analytical techniques used for assessment of product-related CQAs of mAbs are considered in light of the analytical speed and ability to measure different CQAs. Furthermore, the state of art modeling approaches for CQA estimation in real-time are presented as a viable alternative for real-time bioproduct CQA monitoring under the process analytical technology and quality-by-design frameworks in the biopharmaceutical industry, which have recently been demonstrated.

Publication metadata

Author(s): Guerra A, von Stosch M, Glassey J

Publication type: Review

Publication status: Published

Journal: Critical Reviews in Biotechnology

Year: 2019

Volume: 39

Issue: 3

Pages: 289-305

Online publication date: 06/02/2019

Acceptance date: 31/08/2018

ISSN (print): 0738-8551

ISSN (electronic): 1549-7801

Publisher: Taylor and Francis Ltd


DOI: 10.1080/07388551.2018.1524362