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231225s2020 xx |||||o 00| ||eng c |
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|a 10.2144/btn-2020-0011
|2 doi
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|a pubmed25n1026.xml
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|a eng
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1 |
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|a Zhang, Shu-Min
|e verfasserin
|4 aut
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| 245 |
1 |
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|a A novel method for removing polyethyleneimine from biopharmaceutical samples
|b improving assay sensitivity of residual DNA qPCR
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|c 2020
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|a Text
|b txt
|2 rdacontent
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|a ƒaComputermedien
|b c
|2 rdamedia
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| 338 |
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|a ƒa Online-Ressource
|b cr
|2 rdacarrier
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| 500 |
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|a Date Completed 31.08.2021
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|a Date Revised 31.08.2021
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|a published: Print-Electronic
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|a Citation Status MEDLINE
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|a Polyethyleneimine (PEI) is a flocculent that is widely used in the downstream purification of monoclonal antibodies. It is an in-process residual that is carried through the drug purification process and strongly inhibits residual DNA quantitation by real-time quantitative PCR assay. Very high sample dilutions (e.g., 1:10,000) can overcome the interference of PEI, but at the cost of DNA assay sensitivity. Diluting samples poses a significant risk to the assay sensitivity needed to satisfy regulatory requirements on the quantitation of residual genomic DNA present per dose (i.e., 10 ng/dose). Removing PEI while retaining DNA, by the use of sodium dodecyl sulfate, heparin and/or sarkosyl can overcome the interference of PEI and allow a more accurate quantitation of residual DNA
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|a Journal Article
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|a PEI
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|a heparin
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|a host cell DNA
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|a qPCR
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|a sarkosyl
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|a spike recovery
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|a Biological Products
|2 NLM
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|a Polyethyleneimine
|2 NLM
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| 650 |
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|a 9002-98-6
|2 NLM
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|a DNA
|2 NLM
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| 650 |
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|a 9007-49-2
|2 NLM
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| 700 |
1 |
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|a Roberts, Matthew
|e verfasserin
|4 aut
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| 700 |
1 |
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|a Jones, Marisa
|e verfasserin
|4 aut
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| 700 |
1 |
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|a Zeitler, Jacob
|e verfasserin
|4 aut
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| 700 |
1 |
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|a Kilby, Greg
|e verfasserin
|4 aut
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| 700 |
1 |
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|a Liu, Aston
|e verfasserin
|4 aut
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| 700 |
1 |
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|a White, John R
|e verfasserin
|4 aut
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| 773 |
0 |
8 |
|i Enthalten in
|t BioTechniques
|d 1991
|g 68(2020), 6 vom: 15. Juni, Seite 353-358
|w (DE-627)NLM012627046
|x 1940-9818
|7 nnas
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| 773 |
1 |
8 |
|g volume:68
|g year:2020
|g number:6
|g day:15
|g month:06
|g pages:353-358
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|u http://dx.doi.org/10.2144/btn-2020-0011
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