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Halo Labs is an innovator in drug product characterization and subvisible particle analysis providing unprecedented product quality insights to improve patient safety. Starting with the launch of its proprietary Backgrounded Membrane Imaging (BMI) technology, Halo Labs continues to push the needle forward, developing paradigm-shifting approaches that enable researchers to better understand their products and protect patients.

Rick Gordon
Rick Gordon, CEO, Halo Labs

We’re pleased to have the opportunity to speak with Halo Labs’ CEO Rick Gordon to learn how the company is positioned to overcome challenges faced by researchers today.

GEN: How have Halo Labs’ products improved drug product development over the past few years?

Before the Horizon®, Halo Labs’ first product, subvisible particle analysis was limited to late-stage formulation and lot release due to the large sample volume requirements of light obscuration and flow imaging microscopy. Measuring subvisible particles and large insoluble aggregates in early development was simply not possible. Subvisible particles, however, are a critical quality attribute that must be quantified throughout product development. The Horizon, powered by BMI, was the first system that allowed scientists to detect harmful particles earlier because of its low-volume approach. BMI is also compatible with USP 788, so our customers now have a method to measure critical quality attributes from early development all the way through lot release.

Aura™ systems build upon the success of the Horizon. They add fluorescence identification capabilities to the arsenal to enable both accurate particle quantification and identification in combination with BMI. Historically, determining the source of formulation problems took months of labor-intensive techniques requiring large volumes of sample — it simply was not practical to identify all the particles present. Now, it only takes a matter of minutes to identify the source of particles in several samples even when thousands of particles are present. This is a complete game changer for improving patient safety and product stability that simultaneously decreases development time and costs.

GEN: What are your company’s biggest opportunities over the next 3–5 years?

The explosion of cell and gene therapies clearly presents our greatest opportunity. Analytical methods for protein therapeutics are being adapted for cell and gene therapy, and customers have told us that many of these methods are limiting because they can’t handle low volumes or complex sample matrices. Aura systems address these issues, giving cell and gene therapy customers subvisible particle measurements with as little as 5 µL for identification of capsid from carrier protein aggregates and direct detection and identification of contaminants like excess Dynabeads® from cell debris, plastics, and fibers out-of-the-box without requiring complex machine learning libraries.

GEN: How is your company able  to adapt to the needs of today’s biotech researchers?

Aura CL
Aura CL utilizes brightfield, side illumination membrane imaging (SIMI), and fluorescence imaging using specific fluorescent dye labeling on the same sample to clearly distinguish CAR-T cells and contaminant Dynabeads in a cell therapy.

When we launched Aura and Aura CL, our instruments pivoted from only quantifying subvisible particles to being able to employ a whole variety of assays. BMI is now a full platform technology. So far, we’ve analyzed subvisible particles, soluble proteins, viral capsids, lipid nanoparticles, and cells. However, the list of what we’re able to analyze is continually expanding. Our unique membrane-based technology increases the reach of our instruments to perform assays like cell viability and cell type ID assays, as well as a multitude of immunoassays. Being able to perform so many different techniques with one instrument is a tremendous advantage for our customers. We take a very application- and customer-centric approach to our business so our customers can be confident they have the latest technologies and are equipped with innovative tools needed to address new regulatory mandates or keep up with emerging drug discoveries and applications. Looking forward, we anticipate that as new analytical methods are needed for the rapidly evolving cell and gene therapy markets, we will be well positioned to deliver those solutions.

To learn more, visit halolabs.com


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