Plasmid DNA production for pharmaceutical use: role of specific growth rate and impact on process design.

Abstract:

:Application of plasmid DNA as pharmaceutical to be used in gene therapy and vaccination has been investigated intensively in recent years. To be able to provide sufficient material that is in accordance with quality of pharmaceutical grade it is mandatory to gain comprehensive process knowledge which is even requested by regulatory agencies. Regarding plasmid DNA production the specific growth rate has been identified as one of the key parameters. The reduction of specific growth rate results in an increase of plasmid DNA formation. However, quantitative explanations that allow for efficient process development and design are still missing. The presented study proposes a model that clearly demonstrates the relationship between specific growth rate and plasmid formation due to identification of the specific plasmid production rate as relevant key parameter. In addition the model is proved to serve as a useful tool in process development and design.

journal_name

Biotechnol Bioeng

authors

Bohle K,Ross A

doi

10.1002/bit.23138

subject

Has Abstract

pub_date

2011-09-01 00:00:00

pages

2099-106

issue

9

eissn

0006-3592

issn

1097-0290

journal_volume

108

pub_type

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