Rational and systematic protein purification process development: the next generation.

Abstract:

:Current biopharmaceutical manufacturing strongly relies on using purification platform processes, offering harmonization of practices and speed-to-market. However, the ability of such processes to respond quickly to anticipated higher quality and capacity demands is under question. Here, we describe novel approaches for purification process development that incorporate biothermodynamics, modern high throughput experimentation and simulation tools. Such development leads to production platform-specific databases containing thermodynamic protein descriptors of major host cell proteins over a range of experimental conditions. This will pave the way for in silico purification process development, providing better process understanding and the potential to respond quickly to product quality and market demands. Future efforts will focus on improving this field further and enabling more rationale in process development.

journal_name

Trends Biotechnol

journal_title

Trends in biotechnology

authors

Nfor BK,Verhaert PD,van der Wielen LA,Hubbuch J,Ottens M

doi

10.1016/j.tibtech.2009.09.002

subject

Has Abstract

pub_date

2009-12-01 00:00:00

pages

673-9

issue

12

eissn

0167-7799

issn

1879-3096

pii

S0167-7799(09)00175-9

journal_volume

27

pub_type

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