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Immunogenicity Integrated

Diagram of what we do: Identification of product-specific risks; Effective risk evaluation / mitigation; Assessment of clinical impact; and High-quality regulatory submissions


  • We want to enhance the development of safe and efficacious biotherapeutic products through better understanding and control of immunogenicity-related risks.
  • We apply an integrated perspective that assesses the impact of immune responses on relevant treatment outcomes.


  • Our goal is to build a risk-based strategy from a sound understanding of scientific, regulatory and commercial priorities for the particular product and therapeutic use.
  • We aim to avoid hurdles for development and registration by clear communication. Our regulatory documentation is designed to “tell a complete story”.