Ensuring Biologics Safety And Integrity With Next Generation Sequencing

Ensuring the safety and integrity of biopharmaceuticals requires rigorous testing to detect potential contaminants and verify product identity. Next-Generation Sequencing (NGS) has emerged as a state-of-the-art solution, offering a rapid, highly accurate method for determining nucleic acid sequences without prior knowledge of a target. This technology allows for the simultaneous sequencing of millions of fragments, delivering results much faster than traditional assays while maintaining the sensitivity needed to detect rare variants.

By integrating NGS into quality control workflows, manufacturers can monitor genetic stability, perform detailed transcriptome analysis, and conduct comprehensive adventitious virus testing. Validated bioinformatics pipelines further ensure that sequencing data is processed with high reliability. Utilizing these advanced workflows replaces time-consuming assays with a cost-effective, regulatory-approved approach that handles diverse sample matrices.