| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 7630742 | Journal of Pharmaceutical and Biomedical Analysis | 2014 | 8 Pages |
Abstract
- “No DNA extraction” direct qPCR was developed for residual DNA quantification.
- Approach combines treatment with PK and SDS followed by Tween 20 in PCR mix.
- Direct qPCR for CHO residual DNA was validated according to ICH guidelines.
- Method was applied to >20 drug proteins with sensitivity down to 0.1Â ppb.
- Direct qPCR also applicable for residual DNA from other organisms (SP2/0, E. coli).
Related Topics
Physical Sciences and Engineering
Chemistry
Analytical Chemistry
Authors
Grit Peper, Alexander Fankhauser, Thomas Merlin, Ana Roscic, Matthias Hofmann, Petr Obrdlik,