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This webinar series 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.
Next-generation sequencing (NGS) is the primary technology used to identify genomic targets for vaccine development. Enhanced options for NGS on Illumina systems now make it possible to identify multiple potentially pathogenic strains of a disease and understand the rate of evolution quickly, with improved precision. Two complementary sequencing methods are used to identify targets for vaccine development. Whole-genome sequencing using the Invitrogen Collibri DNA Library Prep Kits provide the entire genomic assembly, offering an improvement over older transposomic methods. Collibri 3ʹ mRNA Library Prep kits provide gene expression insights into host-pathogen interactions that can be used to refine genomic targets for vaccine development.
Synthetic biology accelerates vaccine development by providing scientists an efficient mechanism to quickly design and test diverse antigen sequences to create favorable vaccine characteristics such as enhancing antigen immunogenicity and improving vaccine stability. Once candidate sequences are determined, GeneArt Gene Synthesis services provide a range of de novo gene synthesis options to fast-track discovery, key to rapid vaccine development.
In just a few months COVID-19 has risen from a regional crisis to a global threat, and drug makers are now scrambling to develop vaccines aimed at thwarting a pandemic. To meet this urgent and life-threatening situation, vaccine developers are actively seeking the most efficient and robust production platforms to accelerate development timelines. Throughput, productivity, and scalability of the expression platform as well as the availability of well-documented production cell lines are key selection criteria when initiating a vaccine development campaign under such urgent circumstances. To this end, the Gibco Expi Expression Systems are complete platforms that can accelerate vaccine development by enabling rapid, high-yield, and scalable production of proteins, viral antigens and viral-like particles from mammalian (ExpiCHO and Expi293) and insect (ExpiSf) cells. By providing flexible and highly productive expression systems for three different cell hosts that employ optimized and chemically defined components, the Expi systems support every stage of vaccine development. This unified, end-to-end approach reduces key product quality risks during development as one can use the same cell line from research to large-scale production while streamlining process development by utilizing integrated reagents for unmatched performance.
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.
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.