Protein Aggregation and Immunogenicity

Conclusions from studies with transgenic mice
Transgenic immune tolerant mice are useful models to
study product-related factors of immunogenicity:
• Some aggregates were shown to be immunogenic, others not
• Immunogenicity of aggregates is dose dependent
• Protein adsorption to non-proteinaceous subvisible particles can
promote antibody formation
• Immune mechanism differs from a classical vaccination reaction:
- No memory
- CD4 + T-cell dependent