Applied Biosystems has launched an integrated real-time PCR system for measuring residual DNA impurities from Chinese Hamster Ovary (CHO) host cells.
The real-time PCR system quantitates these nucleic acid impurities in four hours.
The ResDNASEQ CHO residual DNA quantitation and PrepSEQ sample preparation kits are the latest additions to the SEQ portfolio of rapid molecular methods for pharmaceutical manufacturing.
The system combines DNA isolation technology in a magnetic bead-based kit for high DNA recovery, with a sensitive qPCR assay, including a genomic CHO standard for generating highly accurate and specific quantitation data.
Expanding the SEQ portfolio to include residual DNA quantitation is expected to broaden the use of Applied Biosystems real-time PCR technologies in pharmaceutical manufacturing.
Philipp Goerttler PhD, quality and compliance scientist at Boehringer Ingelheim, says: 'Based on our current evaluation results, the Applied Biosystems kit allows accurate quantification of CHO DNA in the picogram range, and will be further evaluated for its suitability in routine testing.'
