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Related Concept Videos

Antigens Involved in Adaptive Immunity01:26

Antigens Involved in Adaptive Immunity

An antigen is any substance the immune system identifies as foreign and potentially harmful to the body, prompting an immune response. Antigens have two functional properties: immunogenicity and reactivity. Immunogenicity is the ability of an antigen to stimulate a specific immune response. At the same time, reactivity describes the antigen's ability to react with the cells and antibodies produced in response to it.
Complete Antigens
Complete antigens possess both immunogenicity and reactivity.
Immunodeficiency Diseases01:25

Immunodeficiency Diseases

Immunodeficiency disorders are conditions in which the immune system's ability to fight infectious disease and cancer is compromised or entirely absent. The immune system comprises a complex network of cells, tissues, and organs that work together to protect the body from potentially harmful invaders. When this system is deficient or not functioning properly, it leaves the body susceptible to infections, diseases, or other complications.
There are three main causes of immunodeficiency disorders...
Drug Toxicity: Allergic Reactions01:30

Drug Toxicity: Allergic Reactions

Drug-related allergies are immune-mediated responses triggered by the administration of pharmacological agents. These hypersensitivity reactions are classified based on the immune mechanisms involved. The four primary types—Type I, II, III, and IV—are mediated by different immunological pathways and exhibit distinct clinical manifestations.Type I Hypersensitivity/ IgE-Mediated Reactions: Immunoglobulin E (IgE) immediately mediates Type I hypersensitivity reactions. Upon initial exposure to a...
Preclinical Development: Overview01:28

Preclinical Development: Overview

Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
Mutagenicity and Carcinogenicity01:25

Mutagenicity and Carcinogenicity

Mutagenicity and carcinogenicity refer to the ability of drugs to cause genetic defects and induce cancer, respectively. The International Agency for Research on Cancer (IARC) classifies agents into four groups based on their carcinogenic potential. Group 1 agents are known human carcinogens; group 2A agents are probably carcinogenic to humans; group 3 agents lack data to support their role in carcinogenesis; and group 4 includes agents for which data support that they are not likely to be...
Development of Immunocompetence01:22

Development of Immunocompetence

The initiation of cell-mediated immunity can be observed as early as the third month of fetal growth, with active antibody-mediated immunity following approximately one month later.
The initial cells that migrate from the fetal thymus settle within the skin and epithelial tissues lining the mouth, digestive tract, and in females, the uterus and vagina. These cells, including skin-based dendritic cells, serve as antigen-presenting cells, playing a key role in T cell activation.
Subsequent T...

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Immunogenicity issues in drug development.

Steven J Swanson1

  • 1Clinical Immunology Department, Amgen Inc., Thousand Oaks, California, USA.

Journal of Immunotoxicology
|October 30, 2008
PubMed
Summary
This summary is machine-generated.

Understanding protein therapeutic immunogenicity is crucial for drug development. This involves detecting and characterizing antibodies to ensure patient safety and therapeutic efficacy.

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Area of Science:

  • Biopharmaceutical Development
  • Immunology
  • Drug Safety

Background:

  • Protein therapeutics are increasingly common, necessitating a thorough understanding of their immunogenicity.
  • Assessing immunogenicity is vital during both preclinical and clinical development phases.
  • Regulatory agencies demand rigorous evaluation of immunogenicity to ensure patient safety.

Purpose of the Study:

  • To provide an overview of immunogenicity considerations for protein therapeutics.
  • To discuss potential causes of protein-induced immune responses.
  • To review current methodologies for assessing immunogenicity and examples of associated issues.

Main Methods:

  • Screening assays (RIP, ELISA, ECL, biosensor-based) detect antibodies against protein therapeutics.
  • Confirmatory assays verify and characterize identified antibodies.
  • Biological assays assess the neutralizing capacity of antibodies on drug efficacy.

Main Results:

  • Various assay platforms exist, each with unique advantages and disadvantages.
  • Antibody detection and characterization are critical for assessing impact on therapeutic benefit.
  • Neutralizing antibodies can significantly affect patient outcomes and safety.

Conclusions:

  • A strategic approach to detecting and characterizing antibodies is essential for protein therapeutic development.
  • Selecting the optimal assay platform is crucial for accurate immunogenicity assessment.
  • Understanding immunogenicity is paramount for ensuring patient safety and maximizing therapeutic benefits.