Plasmids are powerful tools utilized in various bioprocesses, from recombinant proteins and vaccines to gene therapy applications such as AAV production. In manufacturing, current regulatory authorities (WHO, EMA, US FDA) require a validated process to measure the amount of residual DNA, including residual plasmid DNA, and prove that it is below accepted limits in the final drug substance.

Currently the preferred method of residual plasmid quantitation is performed by home-brewed real-time PCR, which requires a lengthy development process and often chain-of-custody issues of reagents and standards.

In this presentation we share the development and validation of a highly sensitive, off-the-shelf solution for the detection of residual kanamycin-resistance plasmid DNA designed to meet regulatory requirements.

In this webinar you’ll learn:

• Overview of current regulatory requirements for residual DNA clearance for biological products including residual plasmid DNA and how this applies to gene therapy and vaccine applications
• Details of a streamlined, automated, off-the-shelf solution to measure residual kanamycin resistance plasmid DNA
• Performance specifications for the new Applied Biosystems™ resDNASEQ™ Quantitative Plasmid DNA – Kanamycin Resistance Gene Kit

• Process Development Scientists
• Analytical Development Scientists
• Quality Control, Quality Assurance Scientists
• Regulatory/CMC Managers