The presence of residual DNA carried by gene therapy products in the body may lead to an increased risk of oncogenicity, immunogenicity, and other toxicity. Current regulatory authorities (WHO, EMA and US FDA) limited the accepted amounts of residual DNA in biological products making it extremely important to have a sensitive method of quantifying residual host cell DNA. Among the methods of detecting residual DNA, qPCR is the most widely used for residual DNA quantitation due to its sensitivity, accuracy, precision, and time-saving capability. In this webinar, we share the development and validation of a new, highly sensitive and accurate integrated solution for detection and quantitation of low level HEK-293 DNA to help meet regulatory requirements.
Webinar participants learn: