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Immunogenicity overview of therapeutic biologics

Immunogenicity overview of therapeutic biologics

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Immunogenicity overview of therapeutic biologics

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  1. Immunogenicity Overview of Therapeutic Biologics

  2. What is Immunogenicity? The propensity of the therapeutic biologics to generate immune responses Wanted immunogenicity Unwanted immunogenicity

  3. Background of Immunogenicity-APC Antigen presentation T cell epitopes Phagosome Antigen + APC Endosome/lysosome <34 AA peptides Golgi apparatus Endoplasmic reticulum Secrete vesicles MHC II Affinity of peptides and MHC MHC II CD4+T DC-T cell assay Surface of APC Peptide-MHC-II complex

  4. Background of Immunogenicity-ADA x

  5. Importance of Immunogenicity in Therapeutic Biologics Development

  6. Importance of Immunogenicity in Therapeutic Biologics Development

  7. Impact of Immunogenicity • Effects on bio-availability EX. 1: first generation therapeutic mAbs • Effect on Safety and Efficacy EX. 2: terminate the development  • Effect on PK including potential cross reactivity to endogenous proteins Inhibition of the function of endogenous protein Injection site reactions Systemic reactions mild or life threatening Formation of ADA (HAMA, HACA, HAHA) Formation of neutralizing antibodies Formation of immune complexes Formation of anti-idiotypic antibodies

  8. Immunogenicity Assessment • Strategy-SIAT ®

  9. Immunogenicity Assessment • Strategy - SIAT ® ADA Assay x x x Detect with labeled (e.g. biotinylated drug) Add serum containing Anti-drug antibodies Immoblize drug

  10. Immunogenicity Assessment Strategy - SIAT ® De-immunization Service Locate T cell epitopes 3D model of Fvdomain (of the antibody) Multiple sequence alignmets(of human and murine) Tcell epitopes Compatibility with the 3D structure Replace T cell epitopes Affinity with HLA allotype

  11. Contact us Address: 45-1 Ramsey Road, Shirley, NY 11967, USA Tel:1-631-871-5806Fax:1-631-207-8356Email: info@creative-biolabs.com Web: www.creative-biolabs.com

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