Module 9 2024

03/09/2024

Analytical Methods Maturing Through Clinical Development

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Potency Strategy Linked to MoA

Start by understanding the mode of action of the protein and the processes involved in potency…..

Example 1 rituximab

Mode of Action: Antibody binds to the target antigen (CD20) present on B cells. It binds via the Fab region of the antibody. However it also recruits the immune system via binding sites present in the Fc region next to the large sugar (glycosylation), this sugar stabilises the binding domain where the immune cells bind (e.g. phagocytes, macrophages, NK cells, complement proteins).

The Organisation for Professionals in Regulatory Affairs

68

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