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T102 - The Use of Next Generation Sequencing to Characterize and Detect Adventitious Viral Agents in Biological Products

‐ May 12, 2020 4:30pm

The power of using advanced technologies in the manufacture and testing of biological products is being recognized across a variety of product platforms. The development and control of biological products using Next Generation Sequencing (NGS) technologies is one modality that is being explored to improve product characterization and further assure product quality. For cell-based products and vaccines, NGS is being considered for use to qualify cell substrates, vaccine virus seeds, and drug substance with respect to vector and virus seed sequence characterization and for the absence of adventitious viral agents that may impact product quality and safety. The use of these methods in replacement to the conventional in vivo methods present significant advantages but also technical and regulatory challenges. The implementation of NGS in the testing and qualification for various steps of cell-based product manufacturing has been initiated by some manufacturers. In addition, there are ongoing discussions among regulatory authorities and industry stakeholders regarding the validation of NGS assays, what data should be submitted, and the best data submission format to facilitate the review of NGS data to support its use in qualifying the process and products with respect to adventitious viral agents. Presentations in this session will introduce the NGS technology, give examples of how this technology can be used for product characterization and as a replacement of conventional methods for adventitious agents testing, and elaborate on regulatory considerations for the implementation of NGS.




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