Paper of the Month: December Edition
Animal tests are still required for batch release of tetanus toxoid vaccines (TTd) to confirm their safety and immunogenicity. In support of a consistency approach that requires only limited use of the animal model, the authors of this study developed a new in vitro degradation assay for verifying the quality of TTd in terms of batch-to-batch consistency and product stability. To this end, one research grade peptide and GMP grade peptides from two manufacturers were subjected to heat stress across a range of temperatures and analyzed with the new degradomics-based assay as well as more conventional techniques, including CD spectroscopy.
HOS comparisons between the control batch and stressed TTd batches based on CD data were sensitive enough to already pick up differences between the reference and toxoids exposed to low temperature stress. Together with data obtained from other established techniques, these results were successfully used to evaluate how well the new assay performs in distinguishing heat-treated batches from reference samples.
Michiels, Tilstra, Hamzink, de Ridder, Danial, Meiring, Kersten, Jiskoot, and Metz. 2020. “Degradomics-Based Analysis of Tetanus Toxoids as a Quality Control Assay.” Vaccines 8: 712.
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