User Group

SC Administration and Immunogenicity Risk; Current Understanding and Future Considerations for Novel Modalities

Sathy Balu-iyer, PhD, SUNY Buffalo, Professor, Pharmaceutical Sciences - drug delivery
Amy Rosenberg, PhD, EpiVax, 
Senior Director, Immunology & Protein Therapeutics
Masano Huang, PhD, BMS,
 Associate Director, Sterile Product Development Group 
Ying Chen, PhD, Pfizer, Senior Director, Clinical Pharmacology Oncology
Sophie Tourdot, PhD, Pfize
r, Associate Research Fellow, BioMedicine Design
Inta Gribonika, PhD, NIH, 
Postdoctoral Fellow, Belkaid lab (NIAID)

To focus on the most important considerations for subcutaneous product development, developers require an understanding of contributing factors to SC and IV immunogenicity and correlation to safety/adverse events following SC route of delivery. To better understand this, our User Group will focus on four topics:

  • SC associated immunogenicity relative to other routes of administration
  • Preclinical and in vitro models clinical relevance in demonstrating immunogenicity
  • Patient-centric SC formulation attributes
  • Immunogenicity considerations for novel SC modalities

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