Antibody Developability Assessment & Stability Prediction
Achieve Low Volume, Data Driven Insights

Don't let limited sample availability stand in the way of developability assessments. With innovative technology, quantitatively analyze subvisible particles and proteins at high throughput with 5 μL – from early stage candidate selection to late stage formulation, identifying the best candidates to commercialize.

A Smarter Way to Screen for Drug Candidates

SEC analysis of a particular mAb sample shows the sample is 97.1% monomer. Bowers, K. (June 11, 2019) “Seeking the Unseen: Sub-Visible Particle Analysis as a Core Analytical Technique”
BMI image for the same mAb sample shows the presence of subvisible particles missed by SEC analysis. Bowers, K. (June 11, 2019) “Seeking the Unseen: Sub-Visible Particle Analysis as a Core Analytical Technique”
Dynamic Light Scattering measurement in assessing long-term stability. At later time points the hydrodynamic radius is relatively constant, suggesting that the sample is stable. Bowers, K. (June 11, 2019) “Seeking the Unseen: Sub-Visible Particle Analysis as a Core Analytical Technique”
BMI measurement in assessing long-term stability. At later time points the subvisible particle count has increased substantially, indicating stability issue is missed by looking at hydrodynamic radius alone. Bowers, K. (June 11, 2019) “Seeking the Unseen: Sub-Visible Particle Analysis as a Core Analytical Technique”

Why Use Aura for Protein Developability?

Because you can achieve so much more insight with much less material:
  • Detect and characterize particles not measured by dynamic light scattering (DLS) or size exclusion chromatography (SEC)
  • Preserve sample using as little as 5 μL per test for early candidate screening and selection
  • Identify critical quality attributes (CQA) early and often
  • Quickly screen a wide range of conditions with our 96-well format
  • Obtain detailed information on particles that other methods can’t deliver, including size, morphology, count, and distribution
  • Move quickly with an analysis time of about 1 minute per sample
  • Evaluate a wide range of particle sizes, measuring 1 μm to 5 mm with high reproducibility
  • Achieve high sensitivity because particles are imaged without the interference of buffer or matrix

Identify Optimal Biologic Candidates:
Low Volume, Early Stage Developability with Aura PTx

Aura PTx is transforming the sample volume limited developability assessment stage by enabling subvisible particle characterization — the most
important critical quality attribute (CQA). Its high throughput, low volume modality enables high-level ranking decision making and reveals the most granular insights into particle formation and stability on a single platform.

Get the Full Picture of Protein Stability

Mechanical stress proved to be an effective tool in drastically lowering the presence of soluble aggregates. Subvisible particle count levels skyrocketed under such conditions—revealing a stark contrast between two parameters related to mAb samples' stability. Adapted from Southall, et al. “Particle analysis as a formulation development tool”, Amer. Pharm Rev. (2011).
Freeze-thawing mAb samples revealed surprisingly low levels of soluble aggregates when analyzed by SEC or icIEF. These results contrast notably with high aggregate counts observed in the subvisible particle range. Adapted from Southall, et al. “Particle analysis as a formulation development tool”, Amer. Pharm Rev. (2011).