Module 9 2024

03/09/2024

Immunogenicity Lessons Learned

Murine 100% mouse

Chimeric 33% mouse

Humanised 10% mouse

Human 0% mouse

Immunogenicity

Still immunogenic but less so: Allotypes vary within and between populations

Human: 0% mouse

The Organisation for Professionals in Regulatory Affairs

59

Quality / CMC Considerations

Day 2: Lecture 5

With

Zeb Younes

The Organisation for Professionals in Regulatory Affairs

60

30