Halo Labs
Revolutionizing Subvisible Particle Analysis

Traditionally, the analysis of subvisible particles during the development of a pharmaceutical formulation was conducted using a traditional microscope, where the identification and counting of proteins and other particulate matter was performed through the naked eyes. Through the years, with the development of newer technologies, pharmaceutical enterprises started utilizing fluidics-based systems to increase the rate and throughput of the analysis. However, such equipment requires higher quantities of expensive formulation samples to obtain the desired results, heightening the demand for a particle analysis system that allows pharma companies to get results with minimal amounts of the sample. Halo Labs’ low-volume, high-throughput particle analysis system, HORIZON, finds, counts, and helps their customers better characterize biopharmaceutical products. “Unlike other particle analysis systems that require milliliters of a sample to produce effective results, HORIZON delivers the same outcome with 25-50 microliters,” says Robert Wicke, CEO of Halo Labs.

To achieve unparalleled subvisible particle analysis, the HORIZON system employs Halo Labs’ proprietary analytical technique - backgrounded membrane imaging (BMI). The BMI technology allows customers to image the particles on top of a coated membrane as if it were a conventional microscope slide. Unlike the traditional particle analysis techniques that require the sample to be mounted on a typical glass slide, Halo Labs captures the subvisible particulate matter with high efficiency by filtering the sample through the company’s specialized membrane. Following this, the HORIZON instrument, using BMI, images the particles clearly to assist clients in effectively characterizing the sample across a broad range of parameters. “With HORIZON, scientists can differentiate subvisible protein aggregates that form in drug candidates as early as a pre-formulation selection because our product requires just 1/10th the amount typically used by competitive systems, and thus what typically used to take two days can be done in two hours on the HORIZON,” explains Dr. John Proctor, VP of marketing.

Unlike other particle analysis systems that require milliliters of a sample to produce effective results, HORIZON delivers the same outcome with 25-50 microliters

Halo Labs leverages AI and machine learning to power the image analysis algorithms that are tuned for the context in which they are executed. According to Wicke, these algorithms “understand” the membrane and identify particles and proteins based on HORIZON’s BMI technology. Further, as more customers start using Halo’s system, the algorithms intuitively learn how different types of particles behave on the membrane. This information on particulates and proteins is helping Halo Labs develop future products that can better identify particles by leveraging software, AI, and hardware techniques.

The advantages of the HORIZON system over traditional imagers are highlighted in a collaboration between Halo Labs and a client who was using a flow-based image analysis system to assess the stability of several biotherapeutic candidates by measuring subvisible particles. However, when the customer’s stress test did not reveal an increase in particle count, the skeptical client approached Halo Labs and asked them to run the samples on the HORIZON system. The analysis with Halo’s product revealed thousands of additional particles in the stressed samples that were too translucent to be detected by the fluidics-based system. HORIZON enabled the client to screen drug candidates quickly and with greater confidence.

Halo Labs is bringing new systems that employ new imaging technology to address key challenges customers face today in particle analysis. The company is relocating to Burlingame, CA in the San Francisco Bay Area by Q2 of 2019 to drive growth in their customer base and access top talent. At the same time, Halo Labs is expanding its global sales and service teams to enable better, more efficient customer access. In addition to the company’s Chinese distributors, Halo Labs is collaborating with Japanese vendors in 2019 to expand the clientele in Asian markets.