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Validating a rapid analysis tools for researching monoclonal antibodies

NPL supports BLOC Laboratories, a Bath University spinout, to independently verify its technology for analysing the stability of advanced therapeutics

Scientists at the University of Bath are developing a cutting-edge digital tool that will make it cheaper, safer and faster for pharmaceutical companies to develop new medicines.

Monoclonal antibodies (mABs) are a class of advanced, high value therapeutics with promising applications in precision medicine, however they are larger and less stable than traditional therapeutic molecules. Therefore, there is uncertainty about the shelf life of mABs and their stability, requiring careful and precise measurements.

BLOC Laboratories’ software, Qualitative Understanding of Bio-molecular Edge-Shift (QUBES), provides high sensitivity measurements of mAB stability by analysing fluorescence spectroscopy data. It is fast and low-cost compared to currently available techniques. As with any innovative solution in a highly regulated industry, there is interest but a need for evidence through independent validation studies.

Through its Measurement for recovery (M4R) programme, NPL supported BLOC Laboratories to run an independent validation of its approach and analysis software.

The independently validated data from NPL confirms the quality of BLOC’s product and in-house processes, providing confidence in QUBES to allow researchers to accurately ‘fingerprint’ a protein’s structure and predict stability under nearly any condition of concentration or formulation.

Alex Jones, Principal Research Scientist, NPL, said: “We tested the QUBES approach using a range of analytical methodologies and found that it tracks subtle changes in protein structure and stability with remarkable sensitivity when compared to established methodologies. The approach is fast and simple to implement.”

Christopher Pudney, Chief Scientific Officer at BLOC Laboratories Ltd, says: “This was a critical piece of work which we couldn’t do at the time. The measurement process was excellent, as you’d expect. But NPL also surpassed itself in bringing expert knowledge on how to get the best out of the experiments and data, provided thorough reporting, and quick delivery of data to an incredibly high professional standard.”

“The data are important, but the crucial thing is it comes from NPL. The name provides a seal of quality which opens doors and ensures customer confidence.”

 

27 May 2021