New biopharmaceuticals require time-consuming testing and clinical trials before approval by regulatory bodies like the Medicines and Healthcare products Regulatory Agency (MHRA) and the Food and Drugs Administration (FDA).

Regulators need to have confidence in measurements made by the drugs industry, which in turn would like to keep measurements to the minimum. But only when there is less uncertainty in the data will regulators be satisfied with less testing.

NPL is working to bridge these two requirements as part of the Measurements for Biotechnology programme. It set out to identify the source of inaccuracies in a common protein measurement technique - Circular Dichroism Spectroscopy. Samples of a standardised protein biopharmaceutical were sent for analysis by 27 different laboratories – with a range of errors and widely varying results.

This is the sort of test outcome that could delay approval of a batch of biopharmaceuticals, which are biologically active and suitable for release. The variations were mostly down to poor calibration and operation of the equipment.

NPL is now developing the training and calibration services to help laboratories get reliable and consistent results.

Find out more about NPL's research in Biotechnology