Module 9 2021

19/03/2021

The Extent of Comparability Data is Related to the nature of the Change

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Additional Comparability Data is Required for Complex, Hard to Characterise, poorly Understood (MoA) Products

•Multimeric Protein •Low purity (Multiple species) •Heavily glycosylated •Multiple Mode of Actions •Highly variable lot to lot • Poorly understood link of attributes to safety and efficacy (e.g. PK)

•Monomeric Protein •Highly pure (Single/few species) •Non glycosylated •Single Mode of Action •Minimal lot to lot variability

• Well understood link of attributes to safety and efficacy (e.g. PK)

Less Risk

More Risk

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