Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Antigens Involved in Adaptive Immunity01:26

Antigens Involved in Adaptive Immunity

784
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...
784
Cross-reactivity00:42

Cross-reactivity

31.8K
Overview
31.8K
Mutagenicity and Carcinogenicity01:25

Mutagenicity and Carcinogenicity

1.5K
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...
1.5K
Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

17
Body:Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
17
Tumor Immunotherapy01:27

Tumor Immunotherapy

731
Immunotherapy is a treatment that boosts or manipulates the immune system to fight diseases, including cancer. For instance, by stimulating an immune response through vaccinations against viruses that cause cancers, like hepatitis B virus and human papillomavirus, these diseases can be prevented. Nonetheless, some cancer cells can avoid the immune system due to their rapid mutation and division. The immune response to many cancers involves three phases: elimination, equilibrium, and escape.
731

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same authorSame journal

Updated Recommendations for the Bioanalysis of Antibody-Drug Conjugates (ADC) from the ADC working group of the AAPS Bioanalytical Community.

The AAPS journal·2026
Same author

Weight Changes in Children and Adolescents with Epilepsy and Overweight/Obesity Treated with Zonisamide.

Childhood obesity (Print)·2026
Same author

Streamlining Diagnosis of Bardet-Biedl Syndrome: New Diagnostic Algorithm With Updated Criteria.

American journal of medical genetics. Part A·2026
Same author

Transcriptomic and metabolite-centric profiling reveal aryl hydrocarbon receptor-mediated cytochrome P450 1A1 autoinduction of the selective modulator PM-4321.

Drug metabolism and disposition: the biological fate of chemicals·2026
Same author

First-in-Human Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of BIIB091, an Oral BTK Inhibitor, in Healthy Adult Participants.

Drug design, development and therapy·2026
Same author

Environmental Determinants of Pediatric Obesity: An Epidemiological Review.

Epidemiologia (Basel, Switzerland)·2026

Related Experiment Video

Updated: Oct 14, 2025

Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety
06:37

Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety

Published on: September 15, 2023

785

Immunogenicity Risk Assessment for Multi-specific Therapeutics.

Mark A Kroenke1, Mark N Milton2, Seema Kumar3

  • 1Amgen Inc, Thousand Oaks, California, USA.

The AAPS Journal
|November 6, 2021
PubMed
Summary

This study presents a hypothetical case for assessing immunogenicity risks of multi-specific biologics in Investigational New Drug applications. It details strategies for evaluating anti-drug antibody risks associated with complex therapeutics.

Keywords:
Anti-drug antibodyBispecific therapeuticImmunogenicity risk assessmentMulti-specific therapeuticOligomeric target

More Related Videos

Rapid In Vivo Assessment of Adjuvant's Cytotoxic T Lymphocytes Generation Capabilities for Vaccine Development
09:03

Rapid In Vivo Assessment of Adjuvant's Cytotoxic T Lymphocytes Generation Capabilities for Vaccine Development

Published on: June 19, 2018

8.8K
Paramyxoviruses for Tumor-targeted Immunomodulation: Design and Evaluation Ex Vivo
12:42

Paramyxoviruses for Tumor-targeted Immunomodulation: Design and Evaluation Ex Vivo

Published on: January 7, 2019

9.7K

Related Experiment Videos

Last Updated: Oct 14, 2025

Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety
06:37

Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety

Published on: September 15, 2023

785
Rapid In Vivo Assessment of Adjuvant's Cytotoxic T Lymphocytes Generation Capabilities for Vaccine Development
09:03

Rapid In Vivo Assessment of Adjuvant's Cytotoxic T Lymphocytes Generation Capabilities for Vaccine Development

Published on: June 19, 2018

8.8K
Paramyxoviruses for Tumor-targeted Immunomodulation: Design and Evaluation Ex Vivo
12:42

Paramyxoviruses for Tumor-targeted Immunomodulation: Design and Evaluation Ex Vivo

Published on: January 7, 2019

9.7K

Area of Science:

  • Biopharmaceutical Development
  • Immunology
  • Drug Safety Evaluation

Background:

  • Immunogenicity is a critical safety concern for therapeutic proteins, potentially leading to reduced efficacy and adverse events.
  • Multi-specific biologics, like bispecific antibodies, present unique immunogenicity challenges due to their complex structure and target interactions.
  • Understanding immunogenicity risk factors is crucial for successful Investigational New Drug (IND) applications.

Purpose of the Study:

  • To provide a hypothetical case study for immunogenicity risk assessment of a multi-specific therapeutic.
  • To illustrate bioanalytical strategies supporting immunogenicity evaluation in IND submissions.
  • To explore the impact of multi-specificity, multi-valency, and target oligomerization on anti-drug antibody (ADA) formation.

Main Methods:

  • Development of a hypothetical bispecific biologic (HC-12) targeting TNFα and IL-17A.
  • Review of known immunogenicity risk factors relevant to large protein complexes.
  • Application of risk assessment principles to the hypothetical case for regulatory submission.

Main Results:

  • The case study demonstrates a structured approach to immunogenicity risk assessment for complex biologics.
  • Exploration of how multi-specificity and target structure influence potential ADA responses.
  • Highlights the importance of tailored bioanalytical strategies for detecting and characterizing ADAs.

Conclusions:

  • A systematic immunogenicity risk assessment is essential for multi-specific therapeutics in IND applications.
  • Factors such as molecular complexity and target characteristics significantly influence immunogenicity potential.
  • Proactive assessment and appropriate bioanalytical methods are key to mitigating immunogenicity risks.