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.