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Automated alkaline lysis for industrial scale cGMP production of pharmaceutical grade plasmid-DNA

✍ Scribed by Jochen Urthaler; Christine Ascher; Helga Wöhrer; Roman Necina

Book ID
118471792
Publisher
Elsevier Science
Year
2007
Tongue
English
Weight
994 KB
Volume
128
Category
Article
ISSN
0168-1656

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## Abstract The advances in gene therapy and genetic vaccination based on plasmid DNA result in an increasing demand of pharmaceutical grade plasmids produced under cGMP. A generic process consisting of a cell disintegration step followed by three different chromatography steps has been developed.

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## Abstract A state‐of‐the‐art in‐line static mixer reactor (ISMR) was invented to lyse __E. coli__ cells and neutralize the cell lysate continuously and efficiently for the extraction of plasmid DNA. It comprised two connected static dynamic mixers, each 0.01 m in diameter and 0.9 m in length, one