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Newsletter Sponsor
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Register Now: How to Develop and Validate a Solution to Measure Residual Plasma DNA
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.
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.
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