Direct real-time quantitative PCR for measurement of host-cell residual DNA in therapeutic proteins

- “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 0.1 ppb.
- Direct qPCR also applicable for residual DNA from other organisms (SP2/0, E. coli).