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 Bioengjournal_title
Biotechnology and bioengineeringauthors
Bohle K,Ross Adoi
10.1002/bit.23138subject
Has Abstractpub_date
2011-09-01 00:00:00pages
2099-106issue
9eissn
0006-3592issn
1097-0290journal_volume
108pub_type
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