Conventional animal testing for quality control of vaccines is lengthy and may require large numbers of animals. To address these limitations, the use of specific biomarkers to evaluate batch-to-batch consistency and the safety of vaccines has been proposed. Specific panels could also be used as novel markers to evaluate adjuvant safety profiles and for safety assessment of inoculation routes.
The QuantiGene multiplex gene expression assays are based on branched DNA (bDNA) technology and allow for direct-from-sample transcriptional profiling. These assays have been used to develop more reliable and robust parameters for testing than conventional animal tests. In addition, with the advent of nucleic acid vaccines such as mRNA vaccines, the QuantiGene technology has been used to evaluate the safety of delivery systems and to monitor the biodistribution of these nucleic acids after administration via different routes. These are important aspects to be determined to demonstrate that the safety proﬁles of these RNA vaccines are comparable to traditional vaccines.
Here we discuss some of these recent advances in evaluation of vaccine quality control and safety utilizing the QuantiGene multiplex gene expression assays.