C15 – Module 3 requirements for Biologics (natural peptide/protein medicines)

This session will provided an overview of Module 3 requirements for natural proteins that are prescription medicines – biological medicines. Differences between peptides and proteins and how their origin has an impact on the way that they are regulated will be discussed. The reasoning behind the various regulatory pathways will be examined. Available qualification and quantification methodologies for these medicines will also be looked at.


Chairperson:Gabrijela Matanovic, Phebra