Researchers at the Paul-Ehrlich-Institut succeeded in developing a cell culture test for tetanus vaccines and thereby removing an animal test from the European Pharmacopoeia.
The Paul-Ehrlich-Institut has successfully participated for many years in the development of medicinal product testing methods that could serve as alternatives to animal testing. Several animal experiments have already been removed from the European Pharmacopoeia due to alternative methods developed by the Institute. Numerous awards have been presented to researchers at the Paul-Ehrlich-Institut since 1998, reaffirming work. The Paul-Ehrlich-Institut was once again successful in 2021 and 2022.
In 2021, a working group in the Microbiology Division led by Professor Isabelle Bekeredjian-Ding established a cell-based, in vitro test for the potency testing of tetanus toxoid vaccines. These results were published in the Nature partner journal "npj/Vaccines" with Dr Olga Ticha as first author.
In the production of the authorised vaccine products against tetanus, the bacterial toxin is inactivated with the help of formaldehyde. The resulting tetanus toxoid is the protective antigen in tetanus toxoid vaccines and is harmless to humans. Animal testing methods for the potency test, which ensures the effectiveness of the vaccines, have been prescribed in the pharmacopoeia for decades.
In the future, the cell-based in vitro test, together with physicochemical and immunochemical methods, could replace the animal tests currently required for the batch testing of tetanus toxoid-containing vaccines. This is another important milestone on the way to animal-free medicinal product testing.
Also in 2021, studies led by Dr Beate Krämer and Dr Heike Behrensdorf-Nicol, scientists in the Veterinary Medicine Division at the Paul-Ehrlich-Institut, led to the complete removal from the European Pharmacopoeia of a test used in the production of tetanus toxoid vaccines. This test required that a sample of each manufactured batch of these vaccines be shown in ten guinea pigs to contain only the non-hazardous toxoid of the bacterium Clostridium tetani and none of the original bacterial toxin. In some cases via their own experimental tests, the researchers and their colleauges were able to show that the animal test is unnecessary.
In 2022, they were awarded the Research Prize of the State of Rhineland-Palatinate.
Experimental quality testing and testing of safety and efficacy parameters of vaccine batches in laboratory tests is indispensable, but often tedious and cost-intensive. The Paul-Ehrlich-Institut demonstrated years of committment to replacing animal experiments, both to introduce improved methods into experimental batch testing as well as to protect animals.
Prof Dr Klaus Cichutek (President of the Paul-Ehrlich-Institut)