Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) today announced the launch of two residual DNA quantification (RDQ) kits to simplify the quantification of host-cell DNA (HCD) in process development, quality control, and biomanufacturing processes.
The new ddPCR™ CHO Residual DNA Quantification Kit andddPCR™ E. coli Residual DNA Quantification Kit allow for direct quantification of host-cell DNA impurities in biopharmaceuticals purified from bacteria (E. coli) or mammalian cells (Chinese hamster ovary) without the need for upfront nucleic acid purification steps. The kits are designed for use with Bio-Rad’s Droplet Digital™ PCR Systems.
HCD levels are tightly regulated in biopharmaceutical products, as high concentrations can potentially pose a safety risk for consumers. Removal of HCD and close monitoring of residual levels throughout the production process must be established to ensure quality and safety of the final biopharmaceutical.
Bio-Rad’s CHO and E. coli RDQ kits combined with its ddPCR technology provide a convenient...
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