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Viral Safety Assurance for mAb

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Bioreactor Protection with the Viresolve® Barrier Filter
August 16, 2018

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Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/VSA-viral-safety-GEN.jpgLearn more on latest findings and insights into viral safety.

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A holistic approach to viral safety relies on a multilayered strategy involving:
  • Careful selection and pre-treatment of raw materials to prevent viruses from entering upstream processes
  • Testing for the presence of viruses
  • Implementing appropriate purification and filtration technologies to remove viruses downstream
A viral contamination can shut down a biopharmaceutical plant for months impacting manufacturing operations, causing significant business disruption and ultimately threatening drug supply and patient safety. Understanding the risk of viral contamination from individual components in the upstream process can be challenging, and must be considered in the context of both the likelihood of a contamination, and the probability that contamination will be detected. We have developed a tool to help quantify viral contamination risk from animal-component free raw materials that can be tailored to the specifics of your process.

There is no single solution that works for every process, and we have developed a broad range of viral safety products and services to meet your diverse needs. Our experts can help you understand the risks and guide product and service selection to efficiently implement a solution tailored to your process needs.


Viral Safety – Risk Calculator

The Virus Risk Calculator tool is an algorithm to quantify the risk of virus contamination from animal-component free raw materials.

Open Calculator