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NC3Rs | 20 Years: Pioneering Better Science
Webinar and video

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. 

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.

Webinar introduction, Professor Klaus Cichutek

How aligned are we across Europe?

Panel discussion moderated by Dr Svein Rune Andersen, Norwegian Medicines Agency, Norway.

Webinar title slide: Panel discussion

Asia: Thursday 28 April 2022

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

Screen grab of Professor Yeowon Sohn

How aligned are we across Asia?

Panel discussion moderated by Dr Ian Ragan, Chair of the NC3Rs working group to review animal use requirements in WHO biologics guidelines.

Title page for WHO Asia Panel discussion

Final Stakeholder Meeting: Tuesday 19 September & Wednesday 20 September 2023

Session 1: Pyrogenicity and Endotoxin testing 

Session 2: Neurovirulence testing 

Session 3: Adventitious agents

Session 4: Potency and Immunogenicity

Session 5: Specific Toxicity Testing

A review of reference standards in batch release testing of biologicals

Closing panel discussion and final remarks