Towards real-time monitoring of therapeutic protein quality in mammalian cell processes.

Abstract:

:Protein biopharmaceuticals are mainly produced in mammalian cells which can perform human-like post-translational modifications crucial to protein function. Subject to high variability, these critical quality attributes should be monitored and controlled during the manufacturing process. However, the large time requirements for analysis have been a bottleneck. Recent advances towards automated and high-throughput techniques, combined with multivariate data analysis, are increasingly providing relevant process knowledge in near real-time. New or re-designed analytical tools suited for monitoring product quality are starting to fit in this landscape. Moreover, omics technologies are expanding our understanding of how intracellular mechanisms and the extracellular milieu influence protein quality and quantity, reshaping the adoption of Process Analytical Technology (PAT) and Quality by Design (QbD) in the biopharmaceutical industry.

journal_name

Curr Opin Biotechnol

authors

Pais DA,Carrondo MJ,Alves PM,Teixeira AP

doi

10.1016/j.copbio.2014.06.019

subject

Has Abstract

pub_date

2014-12-01 00:00:00

pages

161-7

eissn

0958-1669

issn

1879-0429

pii

S0958-1669(14)00121-9

journal_volume

30

pub_type

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