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Minimize impact of residual DNA impurities
Ensuring the safety and quality of monoclonal antibody (mAbs) therapeutics is a top priority, and one crucial aspect is the quantification of residual host cell DNA during the manufacturing process. Host cell DNA refers to the genetic material derived from cells like CHO or HEK293, which are commonly utilized in the production of monoclonal antibodies. Regulatory bodies emphasize the significance of controlling and monitoring the amount of residual host cell DNA, therefore it is essential to demonstrate that any host cell impurities are effectively eliminated or reduced to levels below the thresholds established by regulatory agencies.
Residual host cell DNA quantitation
The Applied Biosystems resDNASEQ Residual DNA Solution was developed to provide reliable and sensitive methods for quantifying residual host cell DNA. These kits feature streamlined workflows with high specificity and sensitivity, enabling precise and efficient detection and quantification of residual host cell DNA in monoclonal antibody production. resDNASEQ kits are available for most commonly used cell lines, supporting both real-time and digital PCR platforms.
resDNASEQ kits for antibody production
The resDNASEQ Residual Host Cell DNA Quantitation System offers a portfolio of real-time and digital PCR assay kits to measure residual DNA levels from a variety of host cell lines used for antibody manufacturing.
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