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 Sf9 and Baculovirus DNA to help meet regulatory requirements.
In this webinar, you will learn:
• Summary of current regulatory requirements for residual host DNA clearance for biological products and what that means for gene therapy applications
• Demonstration of a streamlined, automated workflow for quick quantification of residual Sf9 host cell DNA and helper baculovirus DNA
• Performance specifications for the new Applied Biosystems resDNASEQ Quantitative Sf9 and Baculovirus DNA system
Who should attend:
• Process Development Scientist
• Analytical Development Scientist
• Quality Control, Quality Assurance Scientist
• Regulatory/CMC Managers