Development Of A Cloud-Based Computational Protocol To Detect Adventitious Viruses Using NGS Transcriptomics Data

By Jalal Siddiqui, Ph.D., Senior Bioinformatics Scientist, and Rohita Sinha, Director of Bioinformatics, Eurofins Viracor

Ensuring the viral safety of biological products like vaccines and monoclonal antibodies is a critical mandate in drug development. While traditional methods remain standard, Next-Generation Sequencing (NGS) offers an unbiased, high-resolution alternative for profiling viral species within complex biological samples. By leveraging transcriptomics data and advanced bioinformatics, it is now possible to detect even trace amounts of adventitious agents with remarkable sensitivity.

This computational approach utilizes a multi-step pipeline—from quality trimming and host-genome subtraction to reference-assisted assembly and taxonomic classification. Integrated with curated databases covering broad viral diversity and specific antibody production contaminants, these cloud-based workflows ensure both data integrity and regulatory alignment with ICH Q5A guidelines. These protocols provide a scalable, secure environment for identifying potential threats to product purity, offering a robust safeguard for modern bioprocessing.