Aura PTx System
Accelerate protein formulation development and screening for therapeutic drug development
Protein stability analysis and preventing aggregation are is crucial when developing therapies. That’s why it’s time to leave flow cell imaging behind.
Speed up protein formulation development and screening with Aura PTx. With just 5 µL of a sample, discover a faster way to detect, count and characterize excipients and drug products at earlier stages of therapeutic development.
Now you can quickly identify and count aggregates that form due to degraded polysorbate in your formulation. And with two-channel fluorescence, determine if aggregation in your protein therapy is caused by proteins or polysorbates in your sample – at the same time.
Aura PTx System
Specifications
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Imaging area |
24.6 mm² |
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Optics |
4x objective |
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Minimum volume |
5 µL (assay dependent) |
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Resolution |
1.0 pixel/µm |
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Detectable size range |
>1 µm (ECD) to <5 mm (ECD) |
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BMI read time |
1 minute/sample |
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FMM read time |
2 FL channels, 30 seconds/sample |
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Software |
Particle Vue 4.x all-in-one Software suite |
Overview
- Learn more with innovative technology. Aura PTx System combines backgrounded membrane imaging (BMI) with two channels of fluorescence membrane microscopy (FMM) to give you protein aggregate data without the need to clean between measurements.
- ID protein aggregates. Accurately detect excipient degradation within your formulations and distinguish between protein and non-protein particles effortlessly.
- Monitor polysorbate degradation. With fluorescence applications, you can track polysorbate degradation to confidently evaluate the stability of your product.
- Analyze small volumes. You only need 5 µL of sample, allowing you to start characterizing protein aggregates earlier in development.
Recommended Use: For the early detection, measurement, and characterization of protein excipients and drug products in therapeutic development.
Integrated protein stability analysis of biologic formulations
Determining the best course of action based purely on morphological features is not advisable if reliability, security, and efficacy are your top priorities. With the help of FMM, the Aura PTx System tells you exactly what is protein (via ThT staining) and what is not, even in mixed particles.
Identify, count, and size degraded polysorbate
Protein formulations frequently include excipients like polysorbate to aid in stability. When polysorbates degrade, it can lead to instability.
The Aura PTx System is the first to use thioflavin T (ThT) and BODIPY FL C16 staining to detect and quantify protein aggregates and polysorbate breakdown. Analyze the stability of the sample in terms of both biology and polysorbate in a single experiment.
High-throughput screening for protein formulations
Unlike traditional high-throughput methods, which predict protein stability based on protein melting point, The Aura PTx System accurately measures the effect of formulations on the stability of proteins. The Aura PTx System incorporates an intuitive platform that can analyze dozens of solutions in just 60 seconds each with minimal stress. Its 96-well automated format makes it highly suitable for use in design-of experiments (DoE) scenarios while needing only a small sample size, so you can feel confident that your drug product is safe and stable at every step.
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Frequently Asked Questions
What is biopharmaceutical formulation?
Biopharmaceutical formulation refers to the process of developing and optimizing the composition and characteristics of biopharmaceutical products, such as protein-based drugs, vaccines, and gene therapies. Formulation development aims to ensure the stability, efficacy, safety, and manufacturability of biopharmaceutical products by selecting appropriate excipients, buffers, pH, and dosage forms.
What makes biologics so difficult to manufacture?
Biologics are challenging to manufacture due to their complexity and sensitivity to manufacturing processes. Unlike small molecule drugs, which are chemically synthesized, biologics are typically produced using living cells or organisms, such as bacteria, yeast, or mammalian cells. The production process involves multiple steps, including cell culture, purification, and formulation, each of which requires careful control to ensure product consistency, purity, and safety. Additionally, biologics are prone to degradation, aggregation, and immunogenicity, further complicating the manufacturing process.
Why are biologics so expensive?
Biologics are often expensive due to the complexities involved in their development, manufacturing, and regulatory approvals. The production of biologics requires sophisticated technologies, specialized facilities, and skilled personnel, which contribute to higher production costs compared to conventional drugs. Additionally, the lengthy and rigorous regulatory approval process, including clinical trials and post-market surveillance, further adds to the overall cost. Furthermore, limited competition from generic alternatives and the high demand for innovative biologic therapies contribute to their high prices.
What is the process characterization of proteins?
Process characterization of proteins involves understanding and optimizing the various steps involved in protein production, purification, and formulation. It aims to identify critical process parameters (CPPs) and their impact on product quality attributes, ensuring robust and reproducible manufacturing processes. Process characterization involves conducting systematic studies, such as design of experiments (DoE), to evaluate process variability, identify potential failure modes, and establish process control strategies to meet product specifications.
What is protein identification and characterization?
Protein identification and characterization involve determining the identity, structure, composition, and properties of proteins. This process is crucial for various applications, including drug discovery, biomarker identification, and biopharmaceutical development. Techniques such as mass spectrometry, chromatography, electrophoresis, and spectroscopy are commonly used to identify proteins, determine their primary sequence, assess post-translational modifications, and characterize their physicochemical properties.
Aura systems identify and characterize proteins by fluorescently labeling the protein aggregates with a dye such as Thioflavin-T (ThT) or performing an immunoassay.
