- 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”.