Author Spotlight: Biological Standardization to Ensure Reproducibility and Harmonization in Research

Researchers at the MHRA South Mimms Laboratories have been developing manufacturing biological standards for over 60 years, and these reference reagents are used to ensure the quality, consistency, and safety of biological medicines and diagnostics. NIB standards from the MHRA support translation of cutting edge therapeutic products, as well as the control of established medicines. At the MHRA South Mimms Laboratories, we use state-of-the-art technologies to produce materials that support the development and regulation of novel therapeutic innovations.

Biological standards remain underutilized by academics in the biological sciences due to a lack of knowledge exchange. This negatively impacts the quality of research and contributes to the reproducibility crisis. Biological standardization ensures experiments are reproducible regardless of where or when they are performed.

A lack of proper knowledge in basic metrological principles and training compromises scientific rigor and negatively impacts reproducibility. Although our protocol focuses on standardizing platelet function measurement, the practice can be applied to any biological system. Applying biological standardization to research practices will not only standardize biological experiments, but also help to address inconsistencies and the lack of harmonization that undermines research.