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Virus Validation for Virus Safety

Step 4

As a manufacturer of human-use bio-pharmaceuticals, you are required to characterize your manufacturing process and prove that your process can effectively remove any virus that could be present or contaminate.

Designing a Validation Study

Viral Clearance can be simulated in scale-down experiments by adding a known quantity of purified virus to the feed stream, then filtering and measuring the virus titer in the filtrate out to a pre-determined end point.


Careful design of your Validation Study helps ensure you meet your LRC and capacity targets.

As you develop your study methodology, consider these points:
  • What specific bioprocess regulations will I need to conform with?
  • How do I construct an effective scale-down model that can produce accurate results under all process conditions?
  • How do I best accomplish the following tasks:

    • Test feedstock to ensure it matches process output
    • Spike feedstock with known Virus quantity
    • Filter per process conditions
    • Sample at intervals to predetermined end point
    • Measure virus titer in filtrate samples

You also need to identify scale-up risks before you conduct a time-consuming and costly experiment. As you design your large-scale manufacturing pilot to verify that your process can grow with your business, consider including the following tests:

  • Developing a buffer flush step to maximize product recovery
  • Implement a conditioning step prior to virus filtration to increase overall process robustness and improve the efficiency of your virus filter

Developing and conducting a Virus Validation study that meets regulatory requirements and generates the data you require does not need to be difficult. Merck has experienced engineers and scientists able to help you navigate these issues with ease – ensuring your ultimate success. Our experienced engineers and scientists can help you:

  • Review your process to insure compatibility with virus clearance best practices and methods
  • Test and ensure that the feed to be used in your validation study has the same performance characteristics as production feedstock
  • Design the validation study, ensuring accurate scale down
  • Determine a sampling plan
  • Review and interpret results

Merck’s Leadership in Alternative Approaches to Virus Validation

In addition, our strong relationships with regulators worldwide allow us to develop products and services designed to help you meet or exceed regulatory requirements. Examples include our work with:

  • Bacteriophage: Merck conducts investigative studies with model virus to insure that your process performs as expected at reduced cost, which contributes to the success of full panel mammalian virus studies. Contact us to find out how this exclusive Merck capability can help ensure the success of your next Virus validation study.

  • Virus Preparation Purity: Merck continues to advocate for purity in virus spikes to ensure comparability and improve the ability to simulate the conditions of a adverse event in production.

Through our relationship with the PDA task force, Merck collaborates with a team of subject-matter experts from industry, academia and/or government agencies to develop and revise highly-valued industry guidelines and prepare comments for PDA on regulatory issues of a global nature.

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