A new Degradomics-based Assay to evaluate the quality of Tetanus Toxoid Vaccines

Posted on: 11/08/2022

Before being released on the market, every batch of manufactured vaccines must be tested to ensure the safety and effectiveness of the products after being administered. For various types of vaccines, this process still relies on the use of animals as currently available in vitro tests only allow to test the drug substance, and not the finished product.

The VAC2VAC project was launched in 2016 “to develop and validate quality testing approaches for both human and veterinary vaccines using non-animal methods”. VAC2VAC is a public-private consortium of twenty partners from eight different countries, involving experts from veterinary and human vaccine industry in a partnership with official medicines control laboratories, academia, translational research organisations, and vaccinology alliances. It has received funding from the Innovative Medicines Initiative 2 and will continue until the end of February 2022.

In the context of this EU project, a new type of assay was developed by researchers from the
Leiden Academic Centre for Drug Research and the Institute for Translational Vaccinology to assess the quality of Tetanus Toxoid Vaccines. This assay mimics the proteolytic degradation processes in antigen-presenting cells by analysing the formation of peptides from treatment of Tetanus Toxoid with recombinant human Cathepsin S, which is an important enzyme involved in antigen processing in vivo. Quantification of the formed peptides was done using liquid chromatography-mass spectrometry which allows to distinguish aberrant Tetanus Toxoids from control Toxoids. The assay demonstrates great potential for stability and batch-to-batch consistency studies to be used as an alternative for in vivo potency studies. It was also found to perform better than the animal tests which the researchers believe should help in avoiding rejection of good batches. The first author of this research article has been nominated for the Leiden University’s C.J. Kok “Discoverer of the Year” award.


Read the full article here: https://www.mdpi.com/2076-393X/8/4/712/htm

Other publications from the VAC2VAC project can be found here: http://www.vac2vac.eu/publications

VAC2VAC project : Vaccine batch to vaccine batch comparison by consistency testing