About The Series
This GenomeWeb eCase study series, sponsored by Thermo Fisher Scientific, addresses key steps in the vaccine discovery and development workflow. Each 15-minute video outlines specific steps and technologies to help accelerate the development of novel and much-needed vaccines.
PART 1 | Presenter: Cris Kinross, Thermo Fisher Scientific
Enhanced, Rapid Target Identification by NGS for Vaccine Development
PART 2 | Presenter: Julie Robinson, Thermo Fisher Scientific
From Synthetic Gene to Vaccine: Confidence with Gene Synthesis Services
PART 3 | Presenter: Roland Leathers, Thermo Fisher Scientific
Harnessing the Power of Protein Expression Systems in Vaccine Development
PART 4 | Presenter: Andrius Kocevas, Thermo Fisher Scientific
Critical Raw Material for mRNA-based Vaccine Development
Accelerated development of mRNA-based vaccine has necessitated the transformation of standard, research grade in vitro transcription reagents into raw material specifically designed and manufactured under advanced quality standards. The TheraPure grade reagents for mRNA-based vaccine represents Thermo Fisher Scientific’s highest level of purity for mRNA synthesis reagents, with products manufactured using high-definition analytics and tightly controlled purity standards. The TheraPure grade portfolio offers a unique integrated solution for mRNA synthesis, including animal origin-free and ampicillin-free enzymes.
Here, we will discuss the quality requirements for critical raw material for commercial mRNA production and ongoing projects to optimize the entire mRNA portfolio to meet fit-for-purpose standards.
PART 5 | Presenter: Stefan Jellbauer, Thermo Fisher Scientific
Multiplex Gene Expression Assays: A Reliable and Efficient Method for the Evaluation of Vaccine Quality Control and Safety
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.