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NC3Rs | 20 Years: Pioneering Better Science
Office-led project

Review of animal use requirements in WHO biologics guidelines

At a glance

In progress
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Syringe removing liquid from vial

Project overview

Biologicals such as vaccines, cytokines, enzymes, and hormones are tested extensively post-licensure as part of routine quality control and batch release testing to ensure the safety and potency of products. The World Health Organization (WHO) is mandated to establish international standards for this purpose and as such their guidelines and recommendations carry significant influence, being adopted by most global regulatory authorities. However, a review of the animal testing requirements within these guidelines has never been conducted and there may be opportunities to adopt the latest non-animal technologies that are being missed as a result.

The findings from this project were presented to WHO ECBS in October 2023. You can find the full report and a searchable database of animal tests identified with recommendations for the implementation of the 3Rs on our dedicated resource page: Review of animal use requirements in WHO biologics guidelines.

We are working with the WHO, with funding from the Bill & Melinda Gates Foundation, to carry out an independent and comprehensive review of WHO guidelines for biologics to determine:

  1. Which animal tests are recommended for the batch release testing of biologicals and vaccines. 
     
  2. What 3Rs principles are already encouraged, what opportunities exist for better implementation of 3Rs principles and alternative test methods within those guidelines, and to make recommendations to WHO on how this could be best achieved. 
     
  3. What barriers exist in different regions which may hinder the adoption of 3Rs approaches by manufacturers, national regulatory authorities, and control laboratories that are responsible for the testing and release of biologicals.

It has been estimated that more than 10 million animals a year are used worldwide in biologicals development and that 80% of these animals are used for routine quality control and batch release tests of licensed products. The use of such a large number of animals puts a significant financial burden on manufacturers and national control laboratories, is time and resource intensive, and the methods themselves can cause significant pain and distress to the animals. Improved adoption of 3Rs principles and non-animal testing strategies will help to reduce the delays and costs associated with product release testing and help support faster access to cheaper products by the global communities who need them most urgently.

The project was approved by the WHO Expert Committee on Biological Standardization (ECBS) which provides guidance to WHO on matters relating to biologicals development and testing, in October 2019: WHO Technical Report Series. 2020; 1024: Section 2.2.2 (p8).

The project is being overseen by an expert international working group to support the review of the guidelines and develop the recommendations that will be submitted to the ECBS for their approval and implementation.

The video below provides a detailed overview of the project

Stakeholder engagement

We have engaged extensively throughout the project with the global biologicals manufacturer and regulator communities to understand the sector and regional perspectives that may impact the adoption of 3Rs approaches. These interactions have informed the recommendations we have made to WHO and will facilitate the integration of 3Rs approaches in biologicals quality control and batch release testing.

Engagement has been primarily through:

Working group members

Name Affiliation
Ian Ragan (Chair) Independent consultant, UK
Cynthia Allen Health Canada
Dave Allen

Inotiv, USA

Contractor supporting the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM)

Uzma Alam African region consultant
Cristina Barbirato Merck, Italy
Martijn Bruysters National Institute for Public Health and the Environment, The Netherlands
Gilles Chenard Janssen Vaccines and Prevention, The Netherlands
Emmanuelle Coppens Sanofi Pasteur
Wlamir Correa de Moura FIOCRUZ / INCQS
Pradip Das Biological E, India
Francis Galaway Medicines and Healthcare products Regulatory Agency, UK
Simeon Gill AstraZeneca , UK
Sunil Goel Serum Institute of India, India
Richard Isbrucker World Health Organisation, Switzerland
Masaaki Iwaki National Institute of Infectious Diseases (NIID); Japan
David Jones Medicines and Healthcare products Regulatory Agency, UK
Carmen Jungbäck International Alliance for Biological Standardization, Switzerland
Mario Landys Finlay Vaccine Institute, Cuba
Robin Levis US Food and Drug Administration, USA
Laurent Mallet European Directorate for the Quality of Medicines and Healthcare, France
Sylvie Morgeaux National Agency for the Safety of Medicines and Health Products, France
Zebun Nahar Incepta Vaccine Ltd, Bangladesh
Volker Oeppling Paul Ehrlich Institut, Germany
Supaporn Phumiamorn Institute of Bilogical Products, Ministry of Public Health, Thailand
Jean-Marie Preaud International Alliance for Biological Standardization, Switzerland
Mitsutoshi Senoh National Institute of Infectious Diseases, Japan
Shahjahan Shaid GSK Vaccines, Belgium
Sarah Sheridan Merck, UK
Dean Smith Health Canada
Yeowon Sohn Seoul National University, South Korea
Paul Stickings National Institute for Biological Standards and Control, UK
Youchun Wang National Institutes for Food and Drug Control, China

Publications