Integrated expertise, advancing immunogenicity science.
Immunogenicity Integrated® brings together complementary scientific and regulatory expertise, applying years of accrued knowledge as one integrated strategy to clarify complex decisions and move programs forward.
Integrated risk based approach from the start
Regulatory science, bioanalytical design, clinical risk, and product quality are deeply interconnected. When these questions are addressed in isolation, strategies become fragmented and important signals can be missed.
Immunogenicity Integrated® connects the relevant expertise from the start, bringing complementary perspectives together around the same product questions to create one coherent immunogenicity strategy.
Where experience makes a difference
The partners of Immunogenicity Integrated® bring hands-on experience across a wide range of modalities, development stages, and regulatory jurisdictions. Together, they use this breadth of knowledge to recognize when established approaches fit, and when new modalities, technologies, or evidence call for an innovative, tailored strategy.
01
Emerging therapeutic modalities
Product-specific immunogenicity strategies for modalities that do not fit established approaches.
02
New approach methodologies (NAMs)
Advancing New Approach Methodologies (NAMs) that can help reduce reliance on animal studies.
03
Evolving bioanalytical strategies
Adapting bioanalytical strategies to new technologies, evidence needs, and contexts of use.
Connected expertise.
One integrated strategy.
Laura, Arno, and Annick work together around each product question, drawing on their complementary perspectives and a wider network of specialist knowledge. The result is clear, coordinated advice shaped by the whole.
Partner | Regulatory, CMC, and clinical strategy Expertise in regulatory strategy, clinical relevance assessments, and risk-based immunogenicity planning across global health authorities.
Partner | Pre-clinical testing, bioanalysis, and translational scienceExpertise in bioanalytical strategy, product quality attributes, CMC-related immunogenicity risk, and method validation.
Partner | Translational & Bioanalytical ScienceExpertise in translational immunology, bioanalytical method design, and bridging pre-clinical to clinical immunogenicity data.
Conceptualize your strategy
Bring your program’s scientific and regulatory questions together: from early risk planning through submission and lifecycle management.