Comparability for Biologics

Process changes made during the manufacture of recombinant proteins can have profound implications on the quality, safety, efficacy and regulatory approval of your product.

This essential 2-day course gives you a practical insight into how to manage process change so as to ensure regulatory compliance and product consistency at all times. With more than 20 industry case studies to work on, this course is your ultimate guide to finding the best ways to satisfy the needs of the Regulators and understand how various process changes may impact the success of your product.

• Understand the key principles behind process change and how they affect your product
• Learn how to design an effective clinical comparability programme
• Analyse the US and EU regulatory requirements following process change
• Discover the best ways to handle change management
• Hear about the latest technologies being employed to characterise products
• Demonstrate comparability based on physiochemical and biological studies
• Discover the “do’s” and “don’ts” of running a comparability study