Module 9 2021

22/03/2021

Assay drug tolerance - Acid dissociation

Drug interference is an issue for therapeutic mAbs: • long half-life (typically 10-20 days) • often administered chronically at high dose, without a wash-out period.

sulfo-Tag

ADA

TmAb TmAb

TmAb TmAb

TmAb TmAb

ADA

+ acid

+ base + assay reagents

ADA

biotin

Depletion of therapeutic Ab e.g., Affinity capture elution (ACE) Solid-phase extraction (SPEAD) pH shift anti-idiotype (PIA)

Impact of acid treatment on ADA integrity?

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Biosimilars

A biosimilar should not demonstrate any clinically meaningful difference compared to its reference product in terms of quality, safety and efficacy.

Comparative immunogenicity assessment is an essential element for demonstration of biosimilarity – aiming to evaluate potential differences in immunogenicity profiles.

Clinical program must include at least one study for comparison of immunogenicity of proposed biosimilar versus reference product.

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