Module 9 2024

05/09/2024

Properties are Driven by the Sum Total of Isoforms and Impurities

• Amino acid seq. • Folding • Oxidation • Deamidation • Glycation • Glycoforms • Fragments • Terminal Lysine

10 8 possible species

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25

CMC Requirements: US vs. EU

US

EU

Tiered statistical approach although guidance withdrawn

Less defined/more flexible

Approach

Often >15 RP and >10 BS

May be less as no statistical equivalence

Number of Batches

Testing requirements

Similar

Acceptable differences

Differences need to be justified

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26

13