Performance Characteristics of Host-Cell DNA Quantification Methods

LEVEL: INTERMEDIATE C onfidence in the reliability and comparability of results is a primary requirement for measurements made in both industrial and clinical environments. The increased uptake and wider application of molecular biological methods requires assurance of the accuracy, reliability, and comparability of the techniques. However, there are a number of difficulties. The variety of available technologies and platforms coupled with a lack of certified reference materials and standard methods are significant challenges to ensuring comparability of measurements. The pace of technological innovation is a further issue in development of standardized approaches. Although all the current methods available for host-cell DNA (HCD) determination fulfill legal and safety requirements, there is a growing need in industry for detailed information on their performance characteristics. We designed this study to investigate performance characteristics and comparability of HCD quantification methods, thus enabling end users to choose the most appropriate method for their analytical requirements. The work was funded by the Measurement for Biotechnology program (www.mfbprog.org.uk), which is one of several initiatives supporting the United Kingdom’s National Measurement System (NMS). Ensuring measurement comparability is one of the fundamental aims of the NMS, which seeks to enable sustainable development and effective application of biotechnology in a number of commercial sectors including the biopharmaceutical industry (1).