Module 9 2024

03/09/2024

needs for its characterisation and the determination of its quality a combination of physico-chemical-biological testing… Purity for a biological

ICH Q6B - The manufacturer should define the pattern of heterogeneity of the desired product and demonstrate consistency with that of the lots used in preclinical and clinical studies.

The Organisation for Professionals in Regulatory Affairs

19

Modifications

• Deamidation

• Phosphorylation

• Disulphide bond scrambling

• Oxidation

• Succinylation

• Sequence variants

• Aggregation

• Sulfation

• Truncation

• Fragmentation

• Carbamylation

• Denaturation

• Glycosylation

• Methylation

• Sialylation

• Hydroxylation

• N-terminal pyroglutamation

• Citrullination

• Glycation

• Nitrosylation

• Lysine clipping

• Acetylation

• Proline amidation

• Cysteinylation

• Alkylation

• Trisulphide bonds

The Organisation for Professionals in Regulatory Affairs

20

10