Immunogenicity / Immunotoxicity Assessment

Why early immunogenicity assessment matters

Biologics and advanced therapies face unique hurdles in development.

Key challenges and solutions we can help you address:

• Regulatory expectations: FDA and EMA demand robust immunogenicity and immunotoxicity data. Early assessment builds confidence, minimizes delays, and strengthens IND submissions.
• Animal model limitations: Traditional models often fail to capture human‑specific immune responses. Regulators increasingly accept in silico and in vitro approaches to reduce reliance on animal testing.
• Unwanted immune responses: Anti‑drug antibodies (ADA) can compromise therapeutic activity and trigger complications if not detected early through immunogenicity testing.
• Regulator‑ready data: We integrate predictive modeling with human‑relevant PBMC assays to generate strong datasets that accelerate development.
• Cost‑effective workflows: Prioritizing lower‑risk sequences in silico, then validating in vitro, reduces expenses while supporting knowledge‑based candidate selection.

Immunogenicity assessment

The good, the bad (and the ugly)

Epibase® platform: Predict and validate immunogenicity risk early

The Epibase® platform helps you identify and reduce immunogenicity risk before clinical development begins. It combines powerful in silico prediction with human in vitro validation to guide smarter candidate selection and safer design.

With the Epibase® platform, you can focus your R&D efforts on the most promising leads, reduce development costs, and move forward with greater confidence.