Old Unionite, Prof Derek Litthauer, Class of 1972, was recently honoured by the UKโ€™s National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) by being asked to be part of an expert international working group that will guide and deliver a new project which aims to reduce the use of animals in the batch release and quality control testing of biological medicines.

Up to 10 million animals a year are used worldwide in the development, production and quality control of biologicals such as vaccines (e.g. diphtheria, tetanus and polio), immunoglobulins (e.g. snake antivenoms), monoclonal antibodies, blood products and hormones.

More than two-thirds of these animals are used for routine quality control batch release tests of licensed products. These tests are expensive, can cause significant pain and distress to the animals and have a high degree of variability which may cause lengthy delays of up to a year to the release of some biologicals and vaccines.

This new project Prof Litthauer will be a part of, will see the NC3Rs collaborating with the World Health Organization (WHO) to review requirements for the use of animals in WHO guidelines for the quality control and batch release testing of biological therapeutics and vaccines.

Co-funded by the Bill & Melinda Gates Foundation, the aim is to help enable manufacturers, regulators, and national control laboratories to apply the latest non-animal testing approaches and strategies to support faster access to vaccines globally.

This project, which is expected to take three years to complete, is an incredible opportunity for all involved to have a significant impact on the use of large numbers of animals on a global scale and Union High School is immensely proud that one of our past learners is playing a part in it.

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Prof Litthauer holds a PhD in Biochemistry and is a specialist in the areas development, manufacturing, evaluation and regulation of vaccines and other biological medicines.

He served as the Director of the University of the Free State-based National Control Laboratory for Biological Products until his retirement in June 2020. He is a member of the South African Health Products Regulatory Authority expert committee on Biological Medicines. In this capacity, he advises SAHPRA regarding the quality of biological medicines and conducts reviews of biological medicines for registration by SAHPRA.

He is also contracted by the WHO as an IT advisor for the WHO vaccine prequalification programme.

He has previously done research on the microbial diversity of extreme environments where he used molecular biology and bioinformatics to assess the microbial diversity in extreme environments.

Currently, Professor Litthauerโ€™s main activities are in the regulatory aspects of manufacturing and quality of biological medicines, especially in the area of accessibility of quality medicines to poorer countries world wide.