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Viral Safety Strategy for mAb: Prevent, Detect, Remove


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Prevent: Raw material control and barrier technology
Detect: Testing for presence of viruses
Remove: Process’s ability to reduce levels of infectious viruses
Our approach to viral safety provides a tailored solution that considers the production cells, raw materials, testing plans, downstream purification operations and experience of the biomanufacturer. We rely on the principles of the biosafety triangle ‘prevent, detect, remove’ to evaluate options for mitigating the risk of viral contamination in the upstream process and for maximizing viral clearance in downstream purification. This holistic approach integrates upstream and downstream, providing confidence in the safety of the entire production process.

Viral Risk Mitigation Strategies

Watch our video to know more about risk mitigation and viral safety
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Viral safety relies on the basic tenets of “Prevent, Detect, Remove”.
  • Carefully select and pre-treat raw materials
  • Test for the presence of viruses
  • Implement appropriate technologies to remove viruses downstream

Prevent

Watch our video to know more about viral contamination prevention in upstream processes
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A major component of a Viral Safety Strategy is preventing viruses from entering the upstream process.
  • Carefully select cell lines and raw materials
  • Implement new virus inactivation or barrier technologies specifically for cell culture media


Detect

Watch our video to learn more about viral detection
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Regulatory authorities’ expectation for manufacturers is that no adventitious virus should be detected in in-process intermediates.


Remove

Watch our video to learn more about virus removal
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Once a virus or adventitious agent enters the upstream process, it may replicate in the bioreactor and presents a risk to the entire downstream process.
  • Demonstrate that the individual unit operations can clear virus
  • Include orthogonal virus reduction operations
  • Demonstrate the effectiveness of your viral clearance step