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 in cell banks, raw materials, and process intermediatesRemove:
Implementation of technologies to remove or inactivate viruses and execute clearance studies to demonstrate process safety
Many biopharmaceutical processes rely on a well-established sequence of unit operations to produce and purify drug products. This templated approach may offer some predictability to viral safety risk mitigation, however should always be considered in the context of the raw materials, molecule properties, and operating parameters of the individual operations.
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 streamline your drug development process and provide peace of mind.
Looking for more insights on regulatory requirements for viral safety?
Watch our series of tech talk videos to know more about viral safety risk mitigation strategies
Read the special report from BPI
, in collaboration with Martin Wisher, Senior Regulatory Consultant for BioReliance® biosafety services.
This special report provides 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. Differences between these documents are highlighted. New technologies for determining the identity of cell substrates and detecting adventitious agent contamination are described.