Scaling EV Isolation for the Clinic: Customised Workflows for EV Therapeutics and EV Diagnostics

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The future of extracellular vesicle isolation for therapeutics and diagnostics is here.

As we increasingly realise the therapeutic and diagnostic potential of extracellular vesicles (EVs), EV therapeutics and diagnostics are moving closer towards the market. However, the EV field faces a daunting challenge: existing EV isolation workflows are proving inadequate for scalable deployment. The optimisation of new, more efficient workflows comes with a hefty price tag and heftier time commitments which can be prohibitive for startups and larger companies alike.

Our collaborations around the world have spurred our own developments in advancing the technology available for EV isolation. This has culminated in the development of an entirely new, highly customisable service, poised to massively shift the scale of EV isolation.

Introducing qEV PurePath

In the bustling conference halls of ISEV 2023, we unveiled qEV PurePath – a collaborative, customisable partnership aimed at conceiving, fine-tuning, testing, and implementing a tailored, high-throughput EV isolation workflow. In doing so, we aim to lessen the burden of EV isolation problem-solving, so that you can direct more of your resources towards refining your EV diagnostic test or EV therapeutic. With the high costs of R&D being a universal truth, we're here to alleviate some of that time pressure and financial strain, propelling you more swiftly and efficiently toward your market objectives – for a fee dwarfed by the costs of you going it alone.

The qEV PurePath service revolves around customisation, which is made possible by our deep-rooted expertise in EV isolation. Central to our qEV PurePath workflow — and its namesake — is our qEV size exclusion column technology. Renowned for its purity, qEV technology serves as a dependable and customisable cornerstone for all qEV PurePath workflows. Conscious of their very different needs, we have steered qEV technology in two distinct directions, tuned to the unique demands of EV therapeutics and EV diagnostics.

qEV PurePath for Therapeutics

EV therapeutics hinge on the pivotal factor of scale — particularly, scale of sample volume. Converting vast amounts of cell culture media into a consistent, concentrated, and pure EV isolate is a monumental challenge. Ensuring the sterility of the product is another formidable hurdle, making automated processing within a sterile environment practically indispensable for safe product generation. So, how does one navigate these complexities?

Our journey to find a solution started with an exciting collaboration with a company honing in on harnessing functional properties of EVs. To meet their need for large-scale separation, we conceptualised and created a qEV column of staggering proportions, one over 400 times larger than our qEVoriginal columns. As these colossal columns must be tailored to every customer, this behemoth could not be offered as a standard, off-the-shelf product. It is also just one part of a successful therapeutics EV isolation workflow. Thus, the qEV PurePath for therapeutics was conceived – an innovation which requires us to deliver far beyond a simple 'add to cart' solution, for what is a highly intricate problem.

We have designed a workflow that can be tailored to the requirements of your starting sample and end goals. Our expertise spans multiple options at each stage of the process. We'll work in tandem with you to develop and test a workflow that is optimised to transform your raw starting sample into a therapeutic-grade isolate. This process includes automation systems tailored to your needs, designed to facilitate scaling with ease.


Figure 1. An exemplar, conceptual qEV PurePath workflow for therapeutics. Step 1 is clarification, which for automated systems is most likely to be in the form of serial filtration steps to eliminate larger contaminating particles. Next we have concentration, for which we recommend our tried and tested tangential flow filtration solution. After concentration, it is time for isolation in the form of a fully customised size exclusion chromatography column based upon qEV technology. Next come quality control steps, where particle size, concentration and zeta potential can be measured using Tunable Resistive Pulse Sensing, followed by assessments of potency and reproducibility (using assays built in partnership). Finally, you store the final, well-characterised and pure product. Pink = EVs; blue = protein; purple = large contaminants.

qEV PurePath for Diagnostics

We appreciate that EV diagnostic requirements stand distinct from those of therapeutics. Scalability for diagnostics primarily concerns the number of tests that can be executed within a given timeframe. You may also be dealing with a diverse array of sample types, each necessitating different workflows to attain the desired concentration and purity levels for your tests. With this in mind, we have harnessed insights garnered through collaborations with diagnostics companies, putting us in a position to devise a workflow that prioritises test scaling and a signal-to-noise ratio, allowing your diagnostic to shine.

To dramatically enhance the throughput of EV isolation for diagnostics, we are in the process of developing two timesaving instruments. The first, the qEV Primera, is being designed to prime or clean four qEV columns simultaneously, readying them for sample loading. The second in development is the qEV Chimera, to allow concurrent operation of multiple qEV columns, facilitating simultaneous isolation from multiple samples. Together, these instruments would accelerate processing speed by twelve-fold at their current configurations. To ensure your pathway towards scaling up and clinical application is a cost-effective one, high-volume, bulk orders of qEV columns would come at a significant reduction in unit cost.

Beyond that, we are actively advancing lipoprotein removal to increase EV purity from biofluids. Our current results in this direction are very promising and we are excited to be able to soon provide a significant step up in lipoprotein removal.


Figure 2. An exemplar, conceptual workflow for qEV PurePath for diagnostics. The first step is clarification to remove large contaminating particles such as cells and cell fragments. For diagnostics, the most likely form this will take will be filtration. Following filtration, qEV isolation at scale will occur, with multiple samples isolated simultaneously. Following isolation, EVs will be concentrated. Finally, your diagnostic test can be allowed to shine. Pink = EVs; blue = protein; purple = large contaminants.

The qEV PurePath to clinical success

With qEV PurePath, you can offload the challenging, time-consuming, and stressful task of optimising EV isolation for diagnostics or therapeutics. You may primarily associate us with qEV columns or Tunable Resistive Pulse Sensing devices, but our capabilities extend far beyond these offerings. Much of our work has taken place behind the scenes, yet it has fostered a wealth of expertise that can propel your therapeutic or diagnostic test into clinical application more swiftly and effectively than you can achieve alone.

Ultimately, we are ready to help you bridge the gap between where you’re at now, and the translation of your EV-based product to clinical trials and beyond.

For more information on how to scale up your EV isolation with qEV PurePath, visit our dedicated therapeutics and diagnostics pages or book a consultation.

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