A Next Generation Sequencing & Bioinformatics Platform to Reveal Adventitious Virus Contaminants
Viral safety testing is an integral part of the Chemistry, Manufacturing and Control (CMC) of biologics throughout development and release of commercial product, since viral contaminants can present a critical safety issue to humans. We now know that the screening of cell substrates, relevant raw materials and manufacturing steps using traditional screening methods are more likely to result in viruses remaining undetected, thus presenting a safety risk. For example, an individual qPCR assay can detect only a single pre-specified virus, thus missing any unspecified viruses.
To better address this safety issue, Covance and Pathoquest use a Next Generation Sequencing (NGS) and bioinformatics platform to interrogate samples on a virome scale in a practical and efficient manner. This platform provides a sensitive test for the presence and identity of adventitious viruses without prior specification of their nucleic acid sequences, as is required for methods like PCR.
The basic concept involves the sequencing of all nucleic acid material present and application of algorithms (filtering steps and taxonomic assignment) to determine the presence and identity of infectious/contaminating viruses. This methodology applies to a variety of matrices including cells, supernatants, raw materials, virus seeds, etc.
Here, we will present a detailed overview of the NGS & bioinformatics technology, its application to the CMC of biologics and validation data of NGS compared to traditional PCR.
Presented by
Christopher Forsdyke,
Associate Director, Biosafety, BioPharmaceutical CMC Solutions
Mr. Forsdyke has spent nearly 20 years in the biopharmaceutical industry and is an expert in virology, molecular biology and bioassays supporting the development and QA/QC of biologic and vaccine products. He has overall responsibility for the Biosafety Department, part of the Covance BioPharmaceutical CMC Solutions Division. More recently, he was responsible for achieving the strategic agreement and technical alignment with Pathoquest to provide Next Generation Sequencing-based viral safety testing.
