Abstract
Antibody formation is an intended physiological reaction to a “non-self” protein intentionally triggered in the case of vaccines. However, an unwanted immune response to a therapeutic protein may lead to a loss of efficacy and/or to severe side effects. The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) issued a multidisciplinary guideline providing general recommendations from a marketing authorisation perspective on how to systematically assess an unwanted immune response following the administration of a biological drug. In this article, we discuss key aspects of this guideline and its concept, with a particular focus on the impact of immunogenicity on benefit/risk estimation of a therapeutic protein.
Keywords: Immunogenicity, biotechnology derived proteins, benefit/risk, risk assessment, regulatory guideline
Related Journals
Anti-Cancer Agents in Medicinal Chemistry
Anti-Inflammatory & Anti-Allergy Agents in Medicinal Chemistry
Current Bioactive Compounds
Current Drug Targets
Current Neuropharmacology
Current Pharmaceutical Design
Current Pharmaceutical Analysis
Current Vascular Pharmacology
Letters in Drug Design & Discovery
Current Drug Discovery Technologies
Related Books
Frontiers in Drug Design and Discovery
New Findings from Natural Substances
Key Heterocyclic Cores for Smart Anticancer Drug–Design Part II
Key Heterocyclic Cores for Smart Anticancer Drug–Design Part I
Pharmaceutical Chemistry and Production: An Introductory Textbook
Evidence-Based Research in Ayurveda against COVID-19 in Compliance with Standardized Protocols and Practices
Pharmaceuticals for Targeting Coronaviruses
Frontiers in Cardiovascular Drug Discovery
Frontiers in Drug Design and Discovery
Medical Applications of Beta-Glucan
26