Module 9 2021

19/03/2021

Modifications

• Deamidation • Oxidation • Aggregation

• Carbamylation • Methylation • Hydroxylation • Citrullination • Nitrosylation • Acetylation • Cysteinylation

• Fragmentation • Glycosylation • Sialylation • N-terminal pyroglutamation • Glycation • Lysine clipping • Proline amidation • Alkylation • Phosphorylation • Succinylation • Sulfation

• Trisulphide bonds • Sequence variants • Truncation • Denaturation • Free cysteine / thiol groups

The Organisation for Professionals in Regulatory Affairs

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How Similar is the Product…..?

Old Process

New Process

The same ?

The same ?

The same ?

8

8 Identification of Critical Quality Attributes, Critical Process Parameters and Critical Material Attribute

The Organisation for Professionals in Regulatory Affairs

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4