Adventitious agent testing

• Metagenomic approaches enable the testing and safe development of various types of vaccines from the R&D stage to the batch release of marketed products
• By testing the process batch, you may lower the risk of finding a contaminant later in your production stages

Identify the integration sites

• To identify the integration sequence, the particular sequence integrated into the cell line and to validate with respect to the product quality during manufacturing
• Identify mutation in the inserted sequence throughout the process

Vaccine cell line characterisation/genetic stability

• NGS is most powerful and reliable tools for full genome characterisation of cell line which enables identity
• Verify working and master seed stock at genomics level
• Throughout cell passage, mutations may occur which potentially changes the final vaccine product. To avoid genetic changes, the vaccine manufacturer should test the identity and integrity of master cell banks, extended cell banks, complementing cell lines or recombinant cell lines expressing transgenes throughout the production process