Fig. 1.

Factors affecting immunogenicity of biotherapeutics

This figure illustrates the main factors that may influence immunogenicity of a biologic at different stages in the drug’s life-cycle. Multiple sources of protein aggregation exist at various points such as product manufacture, storage, shipping and drug infusion. In addition, containers of the product may lead to exposure to foreign particles such as rubber or silicone particles from stoppers and may act as immunological adjuvants. Post manufacture and drug approval, treatment-related factors and the detection of anti-drug antibodies (green and blue boxes) are potential modifiable factors on immunogenicity from a clinician perspective.