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2-day course

Viral Safety and Clearance in Bioprocessing

Familiarize yourself with the best practices for viral safety and clearance in bioprocessing

Course overview

Protect patients and protect yourselves by attending this two-day course ensuring that you fully understand how to safeguard your biologic from viral contamination! With the rapid growth and dependency on the biological drug market, now is the time to ensure that you are employing the best analytical and clearance techniques to guarantee safety. Over two days you will explore in an interactive environment the sources of viral contamination, regulatory expectations, techniques to assess viral clearance and ways to mitigate risks and changes.

What will you learn?

Viral contamination

Understand the consequences of viral contamination on business operations, reputation and patient safety, and discover the different sources of viral contamination and the most common culprits

Regulatory requirements

Familiarize yourself with regulatory expectations and guidelines that assure viral safety in biological drug products

Viral log reduction

Calculate viral log reduction and understand how this can demonstrate adequate viral removal from your product

Analytical techniques

Learn about the best analytical techniques you can use to detect viruses in both your upstream and downstream process operations

Remove viruses

Understand the best techniques to inactivate and remove viruses from your bioprocess, including UV treatment and nanofiltration

Viral safety in the future

Discuss how industry evolution, such as the emergence of Cell & Gene Therapy and Continuous Processing are likely to impact viral safety

Who is this course for?

This course is for anyone involved in the bioprocessing of biological drugs including departments such as:

  • Cell line development
  • Upstream processing
  • Downstream processing
  • Engineering
  • Viral Safety
  • Quality Assurance
  • Quality Control
  • Regulatory Affairs
  • Risk Assessment