Skip main navigation

Hurry, only 4 days left to get one year of Unlimited learning for £249.99 £174.99. New subscribers only. T&Cs apply

Find out more

Immunogenicity Overview


The clinical consequences of antibody formation vary with the type and quantity of antibody present, and it may effect drug PK, PD, efficacy, and safety. Preclinical immunogenicity is not predictive of clinical immunogenicity in humans, but it helps to understand the findings in a toxicological venue. Assays for ADA detection are grouped into two categories: binding assays and neutralizing antibody assays, which result in different clinical implications.

Immunogenicity is presented in two perspectives: Product oriented attributes include structural variation, biologics formulation, manufacturing process and binding assay utilized. Patient oriented attributes include dose, route, dosing frequency, time length of administration, and idiosyncrasy. Preclinical and clinical assessments of immunogenicity are requited for biologics development.

This article is from the free online

Pharmacotherapy: Understanding Biotechnology Products

Created by
FutureLearn - Learning For Life

Reach your personal and professional goals

Unlock access to hundreds of expert online courses and degrees from top universities and educators to gain accredited qualifications and professional CV-building certificates.

Join over 18 million learners to launch, switch or build upon your career, all at your own pace, across a wide range of topic areas.

Start Learning now