Roche MagNA Pure LC 2.0 system for monitoring DNA in therapeutic proteins and monoclonal antibody drugs

To ensure product safety, clearance of host-cell DNA is essential when manufacturing therapeutic proteins and monoclonal antibody (mAB) drugs. Using the MagNA Pure LC 2.0 System from Roche, scientists have developed and validated an automated process for monitoring clearance of Chinese hamster ovary (CHO) cell DNA during the capture and polishing steps, when processing therapeutic proteins and mAB drugs.

Automated DNA monitoring during manufacturing eliminates the need to perform manual DNA extraction that can create analytics bottlenecks during process development and routine testing. Automated DNA isolation, using the product, results in high DNA recovery rates and subsequent highly sensitive qPCR with the LightCycler 480 Real-Time PCR Instrument. MagNA Pure LC DNA purification eliminates: manual dilution of high-protein and high-DNA loads; manual acidic sample neutralisation; and manual carrier RNA addition.

Roche has produced validation data comparing DNA extraction of manufacturing samples spiked with CHO DNA using the product and competitive instrumentation. In contrast to the other instrumentation, the product did not require manual sample preprocessing, additional proteinase K pretreatment, sample neutralisation and dilution or carrier RNA. The MagNA Pure LC DNA System isolation was shown to require less hands-on time for higher performance than the competitive instrumentation.

This system of automated sample preparation can therefore be productively used to reduce analytics bottlenecks during in-process development and quality control of therapeutic proteins and mAB drugs.