Presented at the PDA Annual Meeting, Anaheim, CA, USA
The term adventitious agent generally describes bacteria, viruses, fungi, and other microorganisms that contaminate products produced using biotechnology. Current molecular methods for detecting adventitious agents require targeted probes for identification of small panels of known contaminants. Untargeted approaches like culture based assays require weeks to complete. NGS provides an untargeted and rapid method for identification of the nucleic acid content of all adventitious agents in a biological sample. A major challenge of using NGS for contaminant testing is fast, efficient, and reproducible analysis of the large volume of data that is generated with each experiment. Here we describe a software platform that supports a complete workflow for analysis of NGS data starting from raw reads and ending with standardized reports.
Genedata Selector™ is composed of a workflow system for quality control, assembly, and annotation of NGS sequence data with a database for storage of reference sequences and analysis results. A reporting component automates the production, management, and distribution of assay results. All analysis workflows and database transactions in the system are logged with user, time, and date information to allow for 21CFR part 11 compliant operations in a GMP environment.