The impact of 3Rs approaches on quality control and batch release testing of biologicals
The NC3Rs is working with the World Health Organization (WHO) to review animal testing requirements within their guidelines for the quality control and batch release testing of biologicals. Co-funded by the Bill and Melinda Gates Foundation, the aim is to identify opportunities for the wider integration of 3Rs approaches and recommend these for implementation by WHO through the Expert Committee on Biological Standardization (ECBS).
Read more about the project: Review of animal use requirements in WHO biologics guidelines.
Regional workshops
We hosted a series of regional workshops to better understand the potential impact of these changes on manufacturers and regulators globally. The output from these workshops informed the recommendations we made to WHO and reduce the barriers for their implementation by ECBS.
- Europe – Wednesday 2 March 2022 (recordings available below)
- Asia - Thursday 28 April 2022 (recordings available below)
- Pan-America – Monday 26 September 2022 (recordings available below)
- Final international stakeholder meeting – Tuesday 19 & Wednesday 20 September 2023 (recordings available below)
All comments/presentations represent the work and opinions of the individuals concerned and are not necessarily the opinion of the NC3Rs.
Europe: Wednesday 2 March 2022
The case for implementing the 3Rs in WHO guidelines
Professor Klaus Cichutek, Paul-Ehrlich-Institut, Germany and outgoing Chair of ECBS.
Dr Elliot Lilley, NC3Rs.
Dr Laurent Mallet, Head of Department of Biological Standardisation, OMCL network & HealthCare.
How aligned are we across Europe?
Dr Volker Öeppling, Head of Section Microbiological Vaccines, Paul-Erlich-Institut.
Dr Geneviève Waeterloos, Sciensano.
Dr Philippe Juvin & Dr Emmanuelle Coppens, Sanofi and representing IFPMA.
Panel discussion moderated by Dr Svein Rune Andersen, Norwegian Medicines Agency, Norway.
The case for implementing the 3Rs in WHO guidelines
Professor Yeowon Sohn, Sungkyunkwan University, Republic of Korea and member of the WHO Expert Committee on Biological Standardization
Dr Elliot Lilley, NC3Rs
Dr Laura Viviani, Developing Countries Vaccine Manufacturers Network (DCVMN)
How aligned are we across Asia?
Dr Koji Ishii, National Institute of Infectious Diseases, Japan
Dr M Kalaivani, Indian Pharmacopeia Commission, India
Dr Huong Vu, National Institute for Control of Vaccines and Biologicals, Vietnam
Dr Wipawee Wongchana, Institute of Biological Products, Thailand
Dr Pradip Das, Biological E, India
Dr Jack Xie, Janssen, China
Panel discussion moderated by Dr Ian Ragan, Chair of the NC3Rs working group to review animal use requirements in WHO biologics guidelines.
Dr Mario Landys, Instituto Finlay de Vacunas, Cuba
Dr Elliot Lilley, NC3Rs
Dr Maria Baca Estrada, Health Canada, Canada
Dr Dean Smith, Associate Director, Centre for Biologics Evaluation, Health Canada, Canada
Dr Emmanuelle Coppens & Dr Philippe Juvin, Sanofi and on behalf of IFPMA
MSc Angélica López Sotelo, Coordinator of Experts of the Biological Products Committee, Mexican Pharmacopeia
Panel discussion moderated by Dr Cynthia Allen, Health Canada.
Panel discussion moderated by Dr Rafael Baptista Silvestrin, Instituto Butantan, Brazil
Ian Ragan, NC3Rs
Richard Isbrucker, Health Canada
Elliot Lilley, NC3Rs
Coenraad Hendriksen, Utrecht University
Session 1: Pyrogenicity and Endotoxin testing
Caroline Vipond, MHRA
Emmanuelle Charton, EDQM
Shahjahan Shaid, GSK
Thierry Bonnevay, Sanofi
M Kalaivani, Indian Pharmacopoeia Commission
Thaís Correa Roche, ANVISA (Brazil)
Panel discussion moderated by Paul Stickings, MHRA.
Session 2: Neurovirulence testing
Emmanuelle Coppens, Sanofi
Javier Martin, NIBSC
Kutub Mahmood, PATH
Robin Levis, FDA/CBER
Panel discussion moderated by Emmanuelle Coppens, Sanofi
Session 3: Adventitious agents
Robin Levis, FDA/CBER
Arifa Khan, FDA
Laurent Mallet, EDQM
Sarah Sheridan, Merck
Panel discussion moderated by Robin Levis, FDA/CBER and Laurent Mallet, EDQM
Session 4: Potency and Immunogenicity
Wlamir Moura, INCQS FIOCRUZ
Richard Isbrucker, Health Canada
Eriko Terao, EDQM
Masaaki Iwaki, National Institute of Infectious Diseases, Japan
Pradip Das, Biological E
Le Sun, Antibody China
Session 5: Specific Toxicity Testing
Paul Stickings, MHRA
Richard Isbrucker, Health Canada
Pradip Das, Biological E
Heike Behrensdorf-Nicol, Paul-Ehrlich-Institut
Emmanuelle Coppens, Sanofi
Panel discussion moderated by Paul Stickings, MHRA
A review of reference standards in batch release testing of biologicals
Paul Stickings, MHRA
Dianna Wilkinson, Consultant
Kata Dix, MHRA
Closing panel discussion and final remarks
Ivana Knezevic, WHO Norms and Standards for Biologicals
José Burgurín, Mexican Pharmacopoeia
Panel discussion chaired by Elliot Lilley and Ian Ragan, NC3Rs
