The need
Monoclonal antibodies (mABs) are a class of advanced, high value therapeutics with promising applications in precision medicine.
Because they are larger and less stable than traditional therapeutic molecules – there is uncertainty about the shelf life of mABs and their stability, so they need careful measurement. BLOC Laboratories’ software - QUBES - provides high sensitivity measurements of mAB stability by analysing fluorescence spectroscopy data. It is fast and low-cost compared to currently available techniques.
Fluorescence spectroscopy uses light to excite molecules, which then re-emit light as they settle, a process acutely sensitive to the molecule’s environment. QUBES analyses measurements of this re-emitted light to provide details of the protein structure, stability and solubility.
As with any innovative solution in a highly regulated industry, there is interest, but buyers are risk averse and need to see evidence of it working through independent validation studies. The COVID-19 pandemic meant it was difficult to run such trials, creating a barrier to BLOC’s ability to sell their product.
The solution
BLOC Laboratories approached NPL through the M4R programme to run an independent validation of its approach and analysis software.
Well characterised protein materials were provided by BLOC for analysis. The NPL team measured these under controlled conditions at a range of temperatures and pH levels. The QUBES analysis was benchmarked against two well-established analysis techniques for measuring protein stability, circular dichroism and dynamic light scattering.
The data showed that QUBES had very high sensitivity and compared favorably to these more conventional approaches.
The impact
As a result of the project, BLOC Laboratories now have independently validated data that confirms the quality of their product and in-house processes. This enables them to engage more rapidly with customers and enhances their competitiveness.
They have already had very positive feedback from customers to the data and anticipate it will provide sufficient reassurance to customers to deliver a 50% increase in the number of leads they can convert to a sale. Based on current interest, this could mean an additional £100,000 in sales this year alone. They are also using the data to apply for an EPSRC grant, alongside NPL. Longer term, the data will form part of their pitch to future investors.
Even without the pandemic, customer trials were slow. This validation has provided a valuable way to circumnavigate much of this complex process accelerating the path from first engagement to sale. QUBES has the potential to reduce development times and costs for their biopharmaceutical customers– which can exceed $1bn – for an exciting emerging class of therapeutics, which could save lives and reduce the burden of disease.