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Introduction
In biotherapeutic development, hitting roadblocks due to insufficient developability assessment is a common and costly setback. Traditional particle analysis methods demand more sample volume than is typically available in early research. At the same time, low-volume techniques often miss subvisible particles—those too large for dynamic light scattering (DLS) and size exclusion chromatography (SEC) but too small to be seen by the naked eye.
Performing this assessment early is crucial for identifying candidates with stability issues and preventing potential failures or expensive reformulations. Finding the most stable candidates and optimal buffer conditions to reduce subvisible aggregation and particle formation—a key quality attribute (CQA) linked to immunogenicity, drug efficacy, and shelf life—is essential. However, limited sample availability often complicates this process, highlighting the urgent need for more efficient assessment methods.
A Smarter Way to Screen for Drug Candidates
Halo Labs’ Aura® PTx offers a smarter way to screen for drug candidates throughout your entire development process. Utilizing only 5 μL of sample material, Aura PTx enables precise characterization of subvisible particles, providing vital insights into protein stability across diverse conditions. With this innovative particle analyzer, you’ll be able to narrow down potential candidates quickly and accurately, from discovery to downstream.
Get the Full Picture of Protein Stability
During the critical candidate selection stage, it’s important to understand a protein’s behavior. Properties such as aggregation, stability, and hydrophobicity must be considered, but using limited methods like SEC or DLS only captures part of the story.
To fully evaluate proteins for antibody developability assessment and preformulation studies, we need to go beyond what these traditional techniques offer. Probing down into the “subvisible” range can reveal details that would otherwise remain hidden. Because automated analysis with background membrane microscopy (BMI) is fast and only needs as little as 5 µL per sample, it can be used early in your developability assessment and preformulation studies to detect larger, insoluble aggregates. This measurement completes the stability picture, letting you make more educated decisions about which candidates to move into development.
In a recent study, Aura was used to characterize subvisible content with a high-throughput, low-volume screen of three different proteins against a platform of 14 industrially relevant buffers and excipient formulations. The most stable protein was identified by quantifying the subvisible content across the different conditions using volumes as low as 5 μL in under three hours of total experimental time, including replicates.
In addition to providing high-level insights during candidate selection, Aura systems enable a deeper understanding of protein aggregation since data can be analyzed at the single-particle level. To demonstrate this, the image gallery (Figure 1) was used to analyze single aggregates formed by Protein B in glycine buffer #14 (learn more about this experiment in Application Note 17). The observed images are subvisible particles stained with the fluorescent dye Thioflavin T (ThT), a well-characterized dye specific for protein aggregates. The red color indicates a strong fluorescence acquired with Aura platform’s Fluorescence Membrane Microscopy (FMM) technology, which helps researchers understand the mechanisms and degradation pathways that influence the biologic’s instability.
Conclusion
Aura PTx sets a new standard in developability assessment by enabling precise subvisible particle characterization, which is important for understanding stability. Its high-throughput efficiency and minimal sample requirements empower effective decision-making from early
candidate selection to late-stage formulation. With just 5 μL, you can uncover deep stability insights and identify top candidates for development and commercialization.
Download our application note to discover the difference with Aura: www.halolabs.com/developability.
