Therapeutic protein products can induce unwanted immune responses with possible consequences on PK, PD, safety and/or efficacy. Health authorities and pharmaceutical scientists recommend a risk-based approach to evaluating and mitigating potential immune responses. Immunogenicity risk assessments focus on product- and patient-related factors that influence likelihood and severity of product specific immunogenicity. The outcome of a cross-functional risk assessment guides the design of the bioanalytical strategy for an investigational therapeutic protein product.
... better understand requirements and relevance of immunogenicity risk assessments in a cross-functional context.
... use available information in context of requirements to define a strategy for assessment of immunogenicity in clinical development.
... acknowledge resulting challenges and opportunities.