Immunogenicity in Protein and Peptide Based-Therapeutics: An Overview

Area of Science:

• Pharmacology
• Immunology
• Drug Development

Background:

• Biological drugs, including fully human ones, can elicit a host immune response called immunogenicity.
• Anti-drug antibodies (ADAs) can alter drug levels, action, and safety by affecting clearance or mechanism of action (neutralizing/non-neutralizing).
• Immunogenicity is a dynamic factor in biological therapy, critical for long-term treatments and assessing secondary loss of response.

Purpose of the Study:

• To review the events of immunogenicity induced by biological drugs.
• To identify factors influencing immunogenicity.
• To discuss the assessment of immunogenicity in biological therapies.

Main Methods:

• Literature review of immunogenicity in biological drugs.
• Analysis of factors affecting drug immunogenicity.
• Summary of methods for assessing immunogenicity.

Main Results:

• Biological drugs inherently possess the potential to induce immunogenicity.
• Factors influencing immunogenicity impact drug efficacy, safety, and clearance.
• Assessment of immunogenicity is vital for therapeutic strategy optimization.

Conclusions:

• Knowledge and management of biological drug immunogenicity are key to optimizing treatment strategies.
• Understanding immunogenicity aids in designing predictive response models for personalized therapies.
• Personalized therapeutic approaches, especially for autoimmune diseases, genetic disorders, and cancer, benefit significantly from immunogenicity management.