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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.
Cell-mediated Immune Responses01:40

Cell-mediated Immune Responses

Overview
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...
Immunological Memory01:23

Immunological Memory

Immunological memory, a pivotal pillar of the adaptive immune system, is responsible for the body's ability to remember and respond more swiftly and effectively to previously encountered pathogens. This remarkable feature is what makes vaccines so effective in preventing diseases.
What is Immunological Memory?
Immunological memory is an integral function of the immune system that allows it to recognize and react more rapidly and effectively to pathogens previously encountered. This feature is...
Vaccinations01:51

Vaccinations

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Special Features of Adaptive Immunity01:20

Special Features of Adaptive Immunity

The adaptive immune system, a crucial component of the overall immune response, offers a highly specialized defense against pathogens. It involves specific cell types and features, enabling it to combat infections effectively and efficiently.
The primary cell types involved in adaptive immunity are T cells and B cells. Each type has a unique role in defending the body against pathogens. T cells are responsible for cell-mediated immunity. They identify and eliminate infected cells directly,...

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Intralymphatic Immunotherapy and Vaccination in Mice
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Intralymphatic Immunotherapy and Vaccination in Mice

Published on: February 2, 2014

Unwanted immunogenicity: lessons learned and future challenges.

Meenu Wadhwa1, Robin Thorpe

  • 1Biotherapeutics Group, National Institute for Biological Standards and Control, Blanche Lane, South Mimms, Potters Bar, Hertfordshire, EN6 3QG, UK. Meenu.Wadhwa@ nibsc.hpa.org.uk

Bioanalysis
|November 19, 2010
PubMed
Summary
This summary is machine-generated.

Assessing biotherapeutic immunogenicity is crucial for regulatory approval and product safety. This review covers methods and challenges in evaluating immune responses to biological drugs.

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Area of Science:

  • Biopharmaceutical science
  • Immunology
  • Drug development

Background:

  • Biological therapeutics can elicit immune responses in patients, leading to varied clinical outcomes.
  • These immune responses range from mild effects to severe adverse events, impacting drug efficacy.
  • Evaluating immunogenicity is essential for regulatory submissions and throughout a biotherapeutic's lifecycle.

Purpose of the Study:

  • To review current bioanalytical methods for assessing biotherapeutic immunogenicity.
  • To discuss available regulatory guidance for immunogenicity testing.
  • To highlight challenges faced by the industry in immunogenicity evaluation.

Main Methods:

  • Review of existing literature on bioanalytical methods for immunogenicity assessment.
  • Analysis of regulatory guidelines pertaining to biotherapeutic immunogenicity.
  • Discussion of industry challenges and best practices.

Main Results:

  • A range of bioanalytical assays are employed for antibody detection and characterization.
  • Regulatory agencies provide guidance on immunogenicity assessment strategies.
  • Standardization of assays and interpretation of results remain key challenges.

Conclusions:

  • A robust immunogenicity testing strategy is vital for biotherapeutic development and patient safety.
  • Validated bioanalytical methods are necessary for accurate assessment.
  • Addressing industry challenges will improve the reliability of immunogenicity evaluations.