CRED Getting the CMC Dossier Right 2024

28/08/2024

Biologicals - Quality Attributes

Key regulatory guidance – ICH Q5 (A to E) and ICH Q6B

Appearance and Description

● Physical state and colour

Identity

● Highly specific

● Multiple tests may be needed

Potency

● Biological activity (Bioassay relevant to therapy)

Quantity

● Protein content

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Biologicals – Quality Attributes

Purity

● Process related (HCP, DNA)

● Cell culture (eg albumin)

● Product related

– Truncated forms – Deamidated forms – Isomerised forms – Mismatched S ‐ S links – Aggregates and fragments

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