Module 9 2024

03/09/2024

Examples of CQA Assignments

Category

pCQA

Category

pCQA

DS IPC DS DP IPC DP

DS IPC DS DP IPC DP

Size-releated variants Size-releated variants

HMWS

X

X

X

Structural variants Structural variants Structural variants

Free sulphydryl X

X

LMWS

X

X

X

Trisulphides

X

X

Charge-related variants (acidic) Charge-related variants (acidic) Charge-related variants (basic) Charge-related variants (basic) Charge-related variants (basic) Charge-related variants (basic) Charge-related variants (basic)

Glycation

X

X

Scrambled disulphides

X

X

Deamidation

X

X

X

Oxidation-related variants Oxidation-related variants

Oxidation (Met residues) Oxidation (Trp residues) Fc functionality

X

X

succinimide

X

X

X

X

asp isomerisation X

X

Potency Potency

X

X

Fab related functionality

X

X

N-terminal Gln/Glu to PyroGlu C-terminal lysines X X

X

X

C-terminal proline amidation

X

X

Fc glycosylation deglycosylated HC X

X X X X X

Fc glycosylation Fucosylation

X

Fc glycosylation Galactosylation X

Fc glycosylation Alpha-1,3-Gal

X

Fc glycosylation Sialiation (including Neu5Gc) X

Fc glycosylation High mannose structures

X

X

The Organisation for Professionals in Regulatory Affairs

17

CQA Assignment

The Organisation for Professionals in Regulatory Affairs

18

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