Roche's MagNA Pure LC 2.0 System for Monitoring DNA in Therapeutic Proteins and Monoclonal Antibody Drugs
Penzberg, Germany, 29 February 2012
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(1).
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 Roche’s MagNA Pure LC 2.0 System 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: (a) Manual dilution of high-protein and high-DNA loads; (b) Manual acidic sample neutralization; and (c) Manual carrier RNA addition.
Roche has produced validation data comparing DNA extraction of manufacturing samples spiked with CHO DNA using Roche’s MagNA Pure LC 2.0 System and competitive instrumentation. In contrast to the other instrumentation, the MagNA Pure LC 2.0 System did not require manual sample preprocessing, additional proteinase K pretreatment, sample neutralization 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. These findings indicate that MagNA Pure LC 2.0 System automated sample preparation can be productively used to reduce analytics bottlenecks during in-process development and quality control of therapeutic proteins and mAB drugs.
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2011, Roche had over 80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 42.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.
(1) EuroBiotechNews No. 11-12, Vol. 10, 2011, pp. 60-62; see https://www.roche-applied-science.com/sis/automated/magna_lc/magna_lc_docs/MPLC_AN_4_Pharma.pdf
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