Review of animal use requirements in WHO biologics guidelines

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.

We have been tasked by the WHO and funded by 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 biologics 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 biologics 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. 

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 WHO Expert Committee on Biological Standardization (ECBS) for their approval and implementation.

Ian Ragan (Chair)

Independent consultant, UK

Dave Allen

Integrated Laboratory Systems, LLC

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

Patricia Aprea

National Administration of Drugs, Foods and Medical Devices (ANMAT), Argentina

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

Angele Costanzo

European Directorate for the Quality of Medicines & HealthCare (EDQM), France

Simeon Gill

Medicines and Healthcare products Regulatory Agency, UK

Sunil Goel

Serum Institute of India, India

Marlies Halder

European Commission, Joint Research Centre,  Italy

Richard Isbrucker

World Health Organisation, Switzerland

Masaaki Iwaki

National Institute of Infectious Diseases (NIID); Japan

David Jones

Medicines and Healthcare products Regulatory Agency, UK

Denis Lambrigts

GSK Vaccines, Belgium

Mario Landys Finlay Vaccine Institute, Cuba

Robin Levis

US Food and Drug Administration, USA

Derek Litthauer

South African Health Products Regulatory Authority and WHO

Zebun Nahar Incepta Vaccine Ltd, Bangladesh

Volker Oeppling

Paul Ehrlich Institut, Germany

Supaporn Phumiamorn

Institute of Bilogical Products, Ministry of Public Health, Thailand

Ute Rosskopf

World Health Organisation, Switzerland

Yeowon Sohn Seoul National University, South Korea

Paul Stickings

National Institute for Biological Standards and Control, UK

Joris Vandeputte

International Alliance for Biological Standardization, Switzerland

Youchun Wang National Institutes for Food and Drug Control, China
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Office-led project

Status:

Active

NC3Rs Scientist

Dr Anthony Holmes

Primary 'R'

Replacement

Scientific Discipline

Vaccines