New standards will improve nucleaic acid and cell counting measurements to support advances in biotechnology
The German standards institute DIN has recognised that the traceable measurement of biomolecules is a key problem in many sectors, as well as fundamental to progress in biotechnology and clinical diagnostics. New standards and guidance are needed to enable the biotechnology and bioscience industries to generate data with higher measurement confidence which will enable data interoperability, reduced product development risks and costs, engender regulatory confidence and compliance, and facilitate international trade.
This project, supported by DIN, has encouraged the uptake of outputs from EMRP projects Bio-SITrace and INFECT-MET, which used state-of-the-art techniques to develop methodology and guidelines for achieving traceability and comparability in biological measurements. Best practice guidance developed by these projects for nucleaic acid quantification and cell counting will be input into new standards through two ISO committees (ISO TC/276 Biotechnology and ISO TC/212 In-vitro diagnostics) and disseminated to user communities through events, webinars and presentations.