De-Risking the Vaccine production
Vaccines play a crucial role in infectious diseases control and are also most important tools in public health. NGS has transformed the fields of basic and clinical research. Genomics is a powerful tool which can decrease the time for discovery, research and vaccine development.
Eurofins Genomics offers an opportunity to vaccine development in the case of pathogens in which the traditional methods have failed. The progresses in high-throughput sequencing and bioinformatics, implies that Genomics is powerful method in vaccine discovery and could be benefited from genomic information. However, genomics is providing new insights into pathogen evolution and epidemiology, virulence mechanisms and host range specificity using comparative genomics. To revolutionize the approach of developing safe and effective vaccines, integration of molecule alike to the pathogen in host genome can be validated using genomics approaches.
Biological materials are used to produce vaccines, so we need to prevent from contamination such as adventitious agents. World Health Organization (WHO) has defined the Adventitious agents as microorganism which are unintentionally introduced into the manufacturing process of a biological product, which includes bacteria, fungi, mycoplasma/spiroplasma, mycobacteria, parasites, rickettsia, protozoa, transmissible spongiform encephalopathy (TSE) agents and viruses. This can be introduced by starting material used for production, such as cell substrates, porcine trypsin, bovine serum, or any other source materials of animal or human origin. So, its important and recommended to test the vaccine at various stages during the vaccine manufacturing to demonstrate the absence of adventitious agents
To identify the integration sequence, the particular sequence integrated into the cell line, and to validate with respect to the product quality during manufacturing and as an “end-of-process control” for batch release. Identify mutation in the inserted sequence throughout the process. NGS is most powerful and reliable tools for full genome characterization of cell line which enables identity. Regulatory authorities require a confirmation of the characteristics of a cell line to ensure safety, reproducibility, and product efficacy.
Eurofins Genomics has developed various approaches in NGS to facilitate the development of safer vaccines
- Adventitious Agent testing
- Identify the integration sites
- Vaccine Cell line Characterization/ Genetic Stability