Next Gen Sequencing Based Biosafety Assessment of Biologics

Genedata Biopharma Partner Symposium 2024, Basel, Switzerland
March 6, 2024

The World Health Organization defines an adventitious agent (AA) as “contaminating microorganisms of the cell culture or source materials that have been unintentionally introduced into the manufacturing process of a biological product.” Traditional methods for detecting adventitious agents require various assays with duration from days to months long for identification of small panels of contaminants. Next-Generation Sequencing (NGS) provides a rapid method for the identification of the nucleic acid content of various adventitious agents and replication in a biological sample. However, analyzing the large amount of data it produces can pose a challenge.

Genedata Selector^® is an end-to-end enterprise software that provides a full solution, from analyzing raw reads to creating standardized and comprehensive assay’s reports. The platform is 21 CFR Part 11 compliant and supports Computerized System Validation (CSV) for NGS systems within GMP environments. The system offers a comprehensive knowledge base for compliant FAIR data management and bioinformatics workflows for automated processing within an enterprise.