Developability Assessment – 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
In the quest to develop the ideal drug candidate, performing developability assessment early can prevent costly missteps.
Unfortunately, traditional particle analysis methods require more volume than may be available during early research stages. In addition, some low volume techniques don’t predict subvisible particles, which fall into a unique size range: too big for DLS and SEC, too small for the eye to see.
That's why we developed Aura PTx for smarter screening throughout your entire development process. With this innovative particle analyzer, you’ll be able to narrow down potential candidates quickly and accurately, from discovery all the way to downstream.
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”
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
During the critical candidate selection stage, it's important to understand a protein's behavior. Properties like aggregation, stability, and hydrophobicity must be taken into account, but using limited methods such as SEC or DLS only captures part of the story.
To completely evaluate proteins for developability assessment and pre-formulations in detail, we need to go even beyond what these traditional techniques offer—probing down into the "subvisible" range can reveal details that would otherwise remain hidden.
Because automated analysis with Backgrounded Membrane Microscopy (BMI) is fast and only needs as little as 5 uL per sample, it can be used early on in your developability assessment and preformulation studies to detect larger, insoluble aggregates.
This measurement completes the stability picture, reducing risk and letting you make more educated decisions about which candidates to move into development.
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).
Featured products
Aura+
With the ability to support the full range of development and manufacturing applications across therapeutic approaches—including protein/antibody therapeutics, gene therapies, cell therapies, and small molecules— Aura+ packs powerful flexibility into a single particle analyzer.
Features
- 5 µL to 10 mL volume
- Particle characterization for protein, cell and gene therapeutics
- Three fluorescent channels for particle identification
- 4x and 20x magnification imaging
Aura PTx
Get the most out of your protein therapy quality measurements with Aura PTx. Our advanced technology can quickly detect, count and characterize excipients and subvisible particles, giving you valuable insights into drug stability during early stages of product development.
Features
- Fluorescence enabled for protein analysis and immunoassays
- Degraded polysorbate and excipient analysis
- High throughput, low volume platform for formulations development
- USP 788 compliant
