Continuous integrated manufacturing of therapeutic proteins.

Abstract:

:With the growth of our understanding of biopharmaceutical processes, a transition from classical batch to continuous integrated manufacturing of therapeutic proteins is taking place across laboratory, clinical and commercial scales. Encouraged by regulatory authorities, this transition is favoured by new emerging technologies as well as by the development of better simulation models. The current status of continuous cell culture and downstream processes and requirements for their successful integration are discussed in this article, with specific reference to product quality attributes.

journal_name

Curr Opin Biotechnol

authors

Karst DJ,Steinebach F,Morbidelli M

doi

10.1016/j.copbio.2017.12.015

subject

Has Abstract

pub_date

2018-10-01 00:00:00

pages

76-84

eissn

0958-1669

issn

1879-0429

pii

S0958-1669(17)30205-7

journal_volume

53

pub_type

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