A NEW automated process for the clearance of host-cell DNA promises higher recovery rates and highly sensitive qPCR.
In the manufacture of therapeutic proteins and monoclonal antibodies, the clearance of host cell DNA is a vital process for product safety.
Roche reports that the newly developed MagNA Pure LC 2.0 system has enabled scientists to develop and validate an automated process to monitor clearance of Chinese hamster ovary (CHO) cell DNA during the capture and polishing steps.
Automated DNA monitoring eliminates the need to perform manual DNA extraction during manufacturing , and so eliminates a potential analytics bottlenecks in process development and testing.
Roche says that automated DNA isolation by MagNA Pure LC 2.0 eliminates three time-consuming stages in the manual process – the dilution of high-protein and high-DNA loads, the neutralisation of acidic samples, and the manual addition of carrier DNA.
The company has produced validation data comparing MagNA Pure and competitive instruments in the DNA extraction of samples spiked with CHO. The Roche approach required manual sample preprocessing, additional proteinase K pretreatment, sample neutralisation and dilution, or carrier RNA, while the competitor did.
The company says these findings indicate that MagNA Pure LC 2.0 can productively reduce analytics bottlenecks during in-process development and quality control of therapeutic proteins and mAB drugs.