Application of Next Generation Sequencing for Biosafety Assessment of Biologics

October 26, 2018

Presented at Bioprocessing Summit, Boston, MA

The term adventitious agent generally describes bacteria, viruses, fungi, and other microorganisms that contaminate products produced using biotechnology. Current culture based or molecular methods for detecting adventitious agents require long incubation times or identify small panels of contaminants. NGS provides a rapid method for identification of the nucleic acid content of 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. The platform is composed of a workflow system for quality control, alignment, 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 21 CFR part 11 compliant operations in a GMP environment.

The system provides a comprehensive knowledge base with reference data to support:

  • Sample data management and reporting
  • Bioinformatics workflows for automated data processing
  • Data management in a compliant platform for operation in a GMP lab
  • Collaborative project based data access in an enterprise software platform

 

 



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