Quality control (QC) testing of biologicals, vaccines, and cell and gene therapy products are paramount. Traditional approaches for necessary QC steps can be limited in their approach. Assays can be low in sensitivity, time consuming, labour intensive, and costly. In addition, many approaches are primer dependent, hypothesis driven, low in resolution, and only provide a positive or negative result. Next-Generation Sequencing (NGS) has the power to revolutionise QC testing techniques. NGS can detect all sequences in the sample and is not limited by primers or prior knowledge of the sample sequence. In cases of contamination detection, NGS enables the detection of agents that may be missed by conventional methods. NGS is rapid, cost effective, high in resolution and sensitivity, and enables identification of agents against chosen databases. NGS is compliant with the 3R initiatives, replace, reduce, refine and has the power to change the way we perform QC steps.
In this presentation we will walk you through NGS for quality control testing, provide an update on the regulatory framework relating to NGS, and share specific case studies where NGS has been used successfully for QC testing.