A novel method for removing polyethyleneimine from biopharmaceutical samples : improving assay sensitivity of residual DNA qPCR
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 sampl...
| Publié dans: | BioTechniques. - 1991. - 68(2020), 6 vom: 15. Juni, Seite 353-358 |
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| Auteur principal: | |
| Autres auteurs: | , , , , , |
| Format: | Article en ligne |
| Langue: | English |
| Publié: |
2020
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| Accès à la collection: | BioTechniques |
| Sujets: | Journal Article PEI heparin host cell DNA qPCR sarkosyl spike recovery Biological Products Polyethyleneimine 9002-98-6 plus... |
| Résumé: | 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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| Description: | Date Completed 31.08.2021 Date Revised 31.08.2021 published: Print-Electronic Citation Status MEDLINE |
| ISSN: | 1940-9818 |
| DOI: | 10.2144/btn-2020-0011 |