Using Next Generation Sequencing To Test Raw Materials Used In Biologics Manufacturing

By Brianna McManus, Maggie Luce, Rebecca Bova, Ph.D., Agnes Yenchi, and Bradley Hasson, MilliporeSigma

When biopharmaceutical products are manufactured using reagents derived from animal sources, there is an inherent risk of introducing viral contaminants into the production process. To address this concern, Next Generation Sequencing (NGS) is increasingly recommended at various stages of manufacturing to detect the presence of adventitious viral sequences. However, the utility of NGS is not limited to in-process testing—it can also be effectively applied to the screening of raw materials prior to their use in production. Implementing NGS at this early stage serves as a proactive measure to mitigate the risk of viral contamination. In this poster, a study was conducted to evaluate the feasibility of applying a validated NGS workflow specifically for the screening of raw materials.

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