Module 9 2021

22/03/2021

Humoral immune response – T-cell dependent

Antigen

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Recombinant proteins – include sequence variants, fusion proteins, chemical modifications, hybrid molecules, … • Hormones, Enzymes, Cytokines • Monoclonal antibodies Biotherapeutics

Murine mAb “-omab”

Chimeric mAb murine variable domain “-iximab”

Humanized mAb murine CDR sequences “-zumab”

Fully human mAb “-umab”

potential for immunogenicity

• Antibodies-derived molecules: antibody-drug conjugates (ADC), bi-specific Abs, nanobodies,… • Newer modalities: gene therapy, cell therapy, …

The Organisation for Professionals in Regulatory Affairs

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