Protein Aggregation and Immunogenicity

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<strong>Immunogenicity</strong> of “native like” aggregates of recombinant human IFNa2a in transgenic mice is dose dependent IgG titer b Wildtype Transgenic 10000 1000 ** *** *** 5/5 4/5 5/5 100 2/5 10 ND A B C D E Increasing aggregate content Hermeling et al., J Pharm Sci 95, 1084-1096 (2006)
Memory study - injection <strong>and</strong> blood sampling scheme Week 1 Week 2 Week 3 t = 0 t = 7 t = 14 t = 21 days … Week 9 Week 4 Wash out Week 10 Week 11 Boost Blood sampling Injection (i.p.) with 5 μg protein
Page 1 and 2: Protein Aggregation and Immunogenic
Page 3 and 4: Immunogenicity - definition T cell
Page 5 and 6: Clinical consequences of immunogeni
Page 7 and 8: Factors influencing immunogenicity
Page 9 and 10: Factors influencing immunogenicity
Page 11 and 12: Aggregates and immunogenicity: clin
Page 13 and 14: Immunogenicity: the formulation mat
Page 15 and 16: Immunogenicity: the formulation mat
Page 17 and 18: Fate of auto-reactive B cells after
Page 19 and 20: B-cell stimulation by epitope array
Page 21 and 22: Protein immunogenicity - our curren
Page 23 and 24: Tools to predict immunogenicity •
Page 25 and 26: Human interferon-a2 immune tolerant
Page 27: Only “native like” aggregates i
Page 31 and 32: Antibody response against aggregate
Page 33 and 34: Aggregated rhIFNb does not act as a
Page 35 and 36: Conclusions from studies with trans
Page 37 and 38: Protein immunogenicity - wrap up St
Page 39 and 40: Thank you ! Hope to see you again a
Page 41 and 42: IgG titer Transgenic immune toleran
Page 43: Switching from IFNβ-1b to IFNβ-1a

Protein Aggregation and Immunogenicity

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