Viral Safety Strategy for mAbs: Prevent, Detect, Remove
Viral safety is a critical aspect of biopharmaceutical/biologics production and relies on the well-established principles of “prevent, detect and remove” to assure drug safety for patients. These principles are the foundation of every viral safety strategy and depend on the approaches outlined below: Prevent:
Careful selection and pretreatment of raw materials to prevent adventitious viruses from entering processesDetect:
Testing for the presence of viruses and other adventitious agents in cell banks, raw materials, and process intermediatesRemove:
Implementation of technologies to remove or inactivate viruses and execute clearance studies to demonstrate process safety
There is no single viral safety solution that works for every process. Working with a partner with experience in all aspects of viral safety assurance can accelerate your drug development process and provide peace of mind.
Webinar Viral risk mitigation strategies: Key considerations in the prevention and detection of viral contamination
Watch our series of tech talk videos to know more about viral safety risk mitigation strategies
Learn more about viral safety risk mitigation strategies
|An overview of the global regulatory framework to ensure the viral safety of biologics, including the latest guidance documents from the US FDA, WHO, European Pharmacopoeia and ICH.
Read the special report from BPI
|Learn more on latest findings and insights into viral safety.
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