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

You might also read

Related Articles

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

Sort by
Same author

Molecular basis of host ATP level modulation by actin-dependent secreted bacterial ATPase and its metaeffector.

Nature communications·2026
Same author

Structural basis and immunogenic efficacy of porcine circovirus type 3 virus-like particle.

Nature communications·2026
Same author

Sexual dimorphism of COVID-19 inspires drug repositioning and host-targeting immunotherapy for viral pneumonia.

Signal transduction and targeted therapy·2026
Same author

Establishment of a Dynamic Ear Inflammation Model in Rats for Acne Vulgaris and Evaluation of Adjuvanted Inactivated <i>Cutibacterium acnes</i>-Based Vaccines Efficacy.

Vaccines·2026
Same author

The crucial but insufficient role of E2s domain's residues 490 and 492 in determining the host tropism of hepatitis E virus.

Nature communications·2026
Same author

An mRNA-encoded scFv antibody targeting the helix-α3 of HPV18 E7 oncoprotein as a novel antiviral strategy.

mBio·2026

Related Experiment Video

Updated: May 14, 2025

In Vitro ELISA Test to Evaluate Rabies Vaccine Potency
09:04

In Vitro ELISA Test to Evaluate Rabies Vaccine Potency

Published on: May 11, 2020

12.3K

Development of In Vitro Potency Methods to Replace In Vivo Tests for Enterovirus 71 Inactivated Vaccine (Human

Xuanxuan Zhang1, Li Yi2, Dan Yu3

  • 1NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, State Key Laboratory of Drug Regulatory Science, Research Units of Innovative Vaccine Quality Evaluation and Standardization, Chinese Academy of Medical Sciences, National Institutes for Food and Drug Control, Beijing 102629, China.

Vaccines
|May 7, 2025
PubMed
Summary

New in vitro methods offer a reliable, animal-free alternative for Enterovirus 71 (EV71) vaccine batch release. These methods align with 3R principles and ensure vaccine quality and stability.

Keywords:
correlationenterovirus 71 inactivated vaccinein vitro relative potencyin vivo potencyreplacement

More Related Videos

Alternative In Vitro Methods for the Determination of Viral Capsid Structural Integrity
12:57

Alternative In Vitro Methods for the Determination of Viral Capsid Structural Integrity

Published on: November 16, 2017

8.0K
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

9.4K

Related Experiment Videos

Last Updated: May 14, 2025

In Vitro ELISA Test to Evaluate Rabies Vaccine Potency
09:04

In Vitro ELISA Test to Evaluate Rabies Vaccine Potency

Published on: May 11, 2020

12.3K
Alternative In Vitro Methods for the Determination of Viral Capsid Structural Integrity
12:57

Alternative In Vitro Methods for the Determination of Viral Capsid Structural Integrity

Published on: November 16, 2017

8.0K
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

9.4K

Area of Science:

  • Vaccinology
  • Immunology
  • Biotechnology

Background:

  • Current Enterovirus 71 (EV71) vaccines rely on variable in vivo potency assays for batch release.
  • There is a need for enhanced quality control and alignment with 3R (Replacement, Reduction, Refinement) principles in vaccine manufacturing.

Purpose of the Study:

  • To develop and validate in vitro relative potency (IVRP) methods for EV71 inactivated vaccines.
  • To establish reliable, animal-free alternatives for vaccine batch release.

Main Methods:

  • Development of manufacturer-specific IVRP methods using conformational epitope-targeting neutralizing monoclonal antibodies (MAbs).
  • Validation of methods per ICH Q14/Q2(R2) guidelines.
  • Characterization of MAb binding sites using Cryo-electron microscopy (Cryo-EM).

Main Results:

  • IVRP methods demonstrated high precision and accuracy, with relative bias/precision/total error ≤ 15%.
  • IVRP results showed significant correlation with in vivo potency assays (p < 0.05, r > 0.9).
  • Proposed IVRP specifications for commercial EV71 vaccines ranged from 0.54-1.50.

Conclusions:

  • Manufacturer-specific IVRP methods are sensitive to process variations and correlate well with in vivo data.
  • These IVRP methods provide a robust, animal-free alternative for EV71 vaccine quality control and batch release.
  • The study successfully established reliable IVRP methods aligning with modern quality control standards.