PTI - international

Interactive Elements

Adults and professionals learn better when the classroom is a vibrant, stimulating place. That's why we incorporate discussions, exercises and quizzes into all of our courses. These activities reinforce training and foster a practical, hands-on educational experience.

The following is one of several interactive exercises included in Complying with Chemistry Manufacturing and Controls (CMC) Requirements for Biopharmaceuticals. Please refer to the course agenda on pages 4 and 5 for additional examples

Example Case: Product X is a monoclonal antibody against a cancer tumor antigen.  The product has been on the market for 5 years.  Your department has modified the ion exchange chromatography to yield a purer product using cheaper resin that reduces processing time through an increased charge. 

1. Divide into groups of 3-4
2. Review the example case (above)
3. Outline what you would include in a comparability protocol
4. Include why you would include this data
5. Discuss and share protocols during a large group debrief