Crux Biolabs Offers Conventional and Spectral Flow Cytometry with Global Harmonisation Between Europe and the U.S.

Flow cytometry is often a critical part of clinical research. It is used to assess multiple parameters, including pharmacodynamics and pharmacokinetics via receptor occupancy assays.  It can also be used for efficiency testing within vaccine studies.  The main advantage of flow cytometry is the ability to measure multiple parameters simultaneously.  For example, you could use one blood sample to identify precisely what kind of population is present or absent within the sample, and at the same time, you could determine the state of activation or the response of these cells within the blood sample.

Conventional vs Spectral Flow Cytometry

At Crux Biolabs, we use conventional and spectral flow cytometry platforms to perform flow cytometry assays. 

Both platforms measure the expression of markers of interest pre-labelled with fluorescent molecules, or fluorochromes. Conventional flow cytometers measure the intensity of these fluorochromes over defined wavelengths, closed to the peak emission of each molecule. Our Beckman Coulter CytoFLEX platform allow us to detect up to 21 parameters simultaneously, which has been sufficient for most clinical studies to date. Unfortunately, the development of complex panels by conventional flow cytometry is limited by the availability of easily discriminable fluorochromes.

On the other hand, spectral flow cytometry measures the entire emission spectra of each fluorochromes. This does not limit the peak emission and allows for more fluorochromes, providing a deeper understanding of the cell populations. Our Cytek Aurora platform allows to measure up to 40 colours, including fluorochromes with emission spectra in close proximity to each other.

For our client, multiplexing more colours mean more markers, less panels, and overall, more cost effective bioanalysis.

It is leading-edge technology that is now available in Australia to support clinical trials and gives more flexibility in selecting and using a greater variety of fluorescent markers, leading to improved resolution and the ability to analyse complex biological samples.  This technique is particularly useful for applications requiring higher-detailed cell characterisation, such as immunology, oncology, and cell-based research.

A Global Alliance to Offer Flow Cytometry Harmonisation

One of the biggest challenges for flow cytometry as part of clinical trials is the harmonisation between equipment and laboratories.  At Crux Biolabs we know the analysis of flow data is extremely complex.  Due to the complexity of the panel (often due to the different platforms used by different organisations) and highly configurable instruments, it can be challenging to normalise or harmonise an assay between different sites. To address this, Crux Biolabs and KCAS Bio formed a global alliance.  Under the alliance, data analysis is done centrally, meaning the results will be consistent for the entire clinical trial.

KCAS Bio is a bioanalytical CRO with laboratories in the US and Europe. They were also looking to solve the challenge of harmonisation between their global locations. The solution was to conduct a full harmonisation of instruments at the Cytek factory – before they even reach any of our facilities. This has ensured all three locations are starting with the same equipment and the same ex-factory configuration.

Additionally, it is vital that all locations be aligned on all processes used, so Crux Biolabs and KCAS Bio team members spent a significant amount of at each other’s sites to standardise training. It also allows for standardised documentation to confirm all locations are running the assays the same way. Now all 3 locations, in all 3 regions, across the 2 companies are performing assays the same way to get consistent outcomes globally.

This makes Crux Biolabs the first bioanalytical laboratory in Australia to be globally harmonised like this. There are two main advantages of using spectral flow cytometry as part of a Phase 1 program.  First, the assays developed at Crux Biolabs can seamlessly transfer to any of our alliance laboratory locations in Europe or in the U.S. This minimises development and transfer cost and time. Secondly, as clinical programs look to expand across multiple regions, our alliance offers a centralised data analysis approach, meaning data acquired at any of the 3 sites will be analysed by the same specialists at the same location to remove inter-analyst variability.

Scientific Expertise and Flexibility from Crux Biolabs

Underpinning this newly formed global alliance is our established team with proven expertise to support complex flow cytometry projects.  We have learnt that to meet our client’s expectations they want direct access to the scientists conducting their studies. They also want complete transparency and a full understanding of what is happening throughout the process.

Unlike many bioanalytical laboratories that use a central project management model, the senior scientists at Crux are in direct communication with sponsors from beginning to end. From the outset, sponsors know exactly what will be delivered and are kept informed at each step of the project.

Crux Biolabs Offers Capacity and Speed – by Design

The team at Crux Biolabs has been designed so that their scientists, senior scientists, and laboratory specialists are resource-planned to offer unusually fast startup times for our new and incoming studies. We use a combination of forecasting and strategic intent to ensure that scientific capacity is available for trials to begin sooner – and ultimately to be completed quicker.

Whereas many competitors offer starting times months from now, Crux Biolabs discusses onboarding within weeks (even days) of a complete assessment of our sponsor’s needs. While unconventional, this practice has become one of the reasons our sponsors have decided to work with us, and some returned time and time again.

Schedule a time with Crux Biolabs to Discuss How to Best Support Your Flow Cytometry Needs

If you and your team are in the early phase of your clinical trials, you may not know what kind of flow assays you would like to employ, or how to best run the assays you have in mind. We invite you to reach out to Crux Biolabs to schedule a time to meet and discuss your needs. We will give you a full understanding of how to run your clinical trial and even give a scope of the best flow cytometry assays to use to meet your goals. We will define these flow cytometry assays using either our conventional platform or our spectral flow platform, balancing cost, time, and complexity. Let us help you choose the path that gives you the most advantage.