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?
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
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
Learn about the best analytical techniques you can use to detect viruses in both your upstream and downstream process operations
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
- Viral Safety
- Quality Assurance
- Quality Control
- Regulatory Affairs
- Risk Assessment