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Plasmid DNA production for pharmaceutical use: Role of specific growth rate and impact on process design
Author(s) -
Bohle K.,
Ross A.
Publication year - 2011
Publication title -
biotechnology and bioengineering
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.136
H-Index - 189
eISSN - 1097-0290
pISSN - 0006-3592
DOI - 10.1002/bit.23138
Subject(s) - plasmid , biochemical engineering , dna , process (computing) , quality by design , computational biology , biology , microbiology and biotechnology , computer science , genetics , downstream (manufacturing) , operations management , engineering , operating system
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. Biotechnol. Bioeng. 2011;108:2099–2106. © 2011 Wiley Periodicals, Inc.