GMP-Validated Adventitious Virus Testing By Next Generation Sequencing

By Dr. Hon Q. Tran, Stefan Borutzki, Dr. Izabela Fabianska, Benjamin Richter, Heiko Julius, Christoph Alarich, Guido Lippert, Guido Schulze, Stefan Schrapel, and Dr. Dietmar Mayer

Safety, quality, and efficacy of biologics are the basis for approving and authorizing through state regulatory bodies. Safety is ensured among other activities by quality controls during the manufacturing process. This also includes testing for unwanted agents which pose a threat to human health. This safety control step is called Adventitious Agent Testing. Here, we specifically deal with viral contamination and name this topic Adventitious Virus Testing (AVT).

Testing for adventitious viruses in regulated industries is a multi-skill discipline involving laboratory work, understanding and application of the NGS technology, knowing relevant bioinformatics algorithms, developing software applications for data analysis, qualifying the required IT infrastructure, and validating the bioinformatics software. All these tasks have to be compliant with the guidelines of regulatory authorities.

This white paper provides you with required knowledge related to the involved regulatory authorities and scientific technologies and disciplines: Next Generation Sequencing (NGS), Bioinformatics and Computer System Validation (CSV).