An Introduction to Immunogenicity

Early detection of immunogenicity reactions is a key component of a drug development programme.

This essential 2-day course shows you how to detect, reduce and characterise unwanted immunogenicity, interpret the last US and EU regulatory guidelines and formulate a winning strategy that you can implement into your business immediately.

Critical steps to detect and characterise unwanted immunogenicity

• Review the fundamentals of immunogenicity
• Understand why proteins can be immunogenic and why immunogenic testing is necessary for your products
• Consider the various methods and formats used to detect unwanted immunogenicity – how they compare and when to employ them
• Learn how to develop, standardize and validate your assays to improve accuracy and robustness
• Apply theoretical knowledge by executing 3 hands-on exercise during the course
• Appreciate and overcome the critical issues in assay validation using real-life examples
• Develop an appropriate risk strategy for your immunogenicity program
• Interpret and implement the latest EMA, FDA and industry documents