In the dynamic lifecycle of a biopharmaceutical drug, from inception to patient use,
stability and material compatibility is crucial. The complex interactions with various surfaces can lead to challenges such as unexpected adsorption, concentration depletion, or the formation of proteinaceous particles.

Proactive screening to reduce risk

Detecting these potential issues early on is essential, as late discovery could disrupt project timelines and result in substantial financial setbacks. Proactive screening for potential surface-induced instabilities during development becomes vital to mitigate risks. This approach enables a smoother development, reducing risk of later failure, for example during final storage testing.

QSense QCM-D: A Surface-Sensitive Solution

Our solution - QSense® QCM-D technology helps you to analyze biopharmaceutical interactions comprehensively. This surface-sensitive method offers insights into molecular adsorption, desorption, and structural rearrangements at the nanoscale, facilitating rapid detection of potential incompatibilities and providing a mechanistic understanding of solid-liquid interface processes.

Key Capabilities of QCM-D for Biopharmaceutical Success

Analyze biopharmaceutical interaction with relevant materials
Using QCM-D you can quickly assess the effect of materials used in manufacturing, storage, and administration on the full formulation early on in development.

Proactive incompatibility detection
Using QCM-D, you can quickly measure the adsorbed amount of the formulation candidate on relevant surface and identify ways to mitigate incompatibilities.
Real-time monitoring of antibody and excipient adsorption
QCM-D analysis can help you understand surfactant action mechanisms and potential as stabilizer in the relevant context.

Assessment for Formulation Development

With QCM-D Analysis, you can:

  • Determine antibody adsorption levels on diverse surface materials
  • Gain insights into molecular arrangements at the surface
  • Identify surfaces susceptible to incompatibility issues
  • Evaluate the influence of excipients on antibody adsorption
  • Explore how variations in concentration, pH, temperature, surface material, or surfactant type impact adsorption levels.

Utilize QCM-D for assessments of manufacturing, storage, and administration materials, providing real-time data on antibody and excipient adsorption. This proactive approach not only enhances your understanding of surfactant mechanisms but also helps to detect potential incompatibilities early by measuring adsorbed quantities, ensuring efficient risk mitigation.

Interested to find out more?

Download the white paper to learn more about how QSense analysis can be used to reduce the risk of late discovery of incompatibilities!

Download White Paper

Get in touch with us to ask questions or discuss our test-your-sample offer.

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