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Related Concept Videos

Drug Product Stability01:16

Drug Product Stability

The long-term stability of drug products is critical to ensuring their quality, safety, and effectiveness over time. Stability directly influences a product's ability to maintain its intended characteristics, ensuring it performs as expected during its intended shelf life. Key attributes such as drug potency, impurities, dissolution, and other physicochemical measures of performance are tested to assess stability. These parameters indicate how well the product retains its quality over time and...

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Related Experiment Video

Updated: Jul 18, 2026

How to Stabilize Protein: Stability Screens for Thermal Shift Assays and Nano Differential Scanning Fluorimetry in the Virus-X Project
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How to Stabilize Protein: Stability Screens for Thermal Shift Assays and Nano Differential Scanning Fluorimetry in the Virus-X Project

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High throughput screening of protein formulation stability: practical considerations.

Martinus A H Capelle1, Robert Gurny, Tudor Arvinte

  • 1Department of Pharmaceutics and Biopharmaceutics, University of Geneva, University of Lausanne, CH-1211 Geneva 4, Switzerland.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|November 17, 2006
PubMed
Summary

High throughput formulation (HTF) platforms streamline protein drug development using microplates for automated sample preparation and analysis. This accelerates understanding of protein properties and degradation pathways, crucial for biopharmaceutical success.

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Area of Science:

  • Biopharmaceutical Development
  • Protein Chemistry
  • Analytical Chemistry

Background:

  • Protein drug formulation is complex due to intricate protein structures and specific physicochemical properties.
  • Understanding protein degradation is critical for successful biopharmaceutical drug development.
  • Current methods can be time-consuming and challenging.

Purpose of the Study:

  • To review the application of high throughput screening techniques in protein formulation development.
  • To highlight the components and methodologies of a protein high throughput formulation (HTF) platform.
  • To discuss techniques and challenges associated with implementing HTF.

Main Methods:

  • Utilizing microplate-based systems for both sample preparation and analysis.
  • Automated dispensing of protein drugs and formulation ingredients (liquid and powder).
  • Employing specific analytical methods, such as intrinsic fluorescence, for assessing protein properties (conformation, aggregation).

Main Results:

  • Protein high throughput formulation (HTF) platforms integrate automated sample preparation and microplate-based analysis.
  • Intrinsic fluorescence is demonstrated as an effective method for analyzing protein aqueous properties.
  • Various techniques suitable for HTF analysis are discussed, alongside implementation considerations.

Conclusions:

  • High throughput formulation (HTF) platforms offer an efficient approach to protein drug development.
  • Microplate-based assays and automated systems are key to HTF success.
  • Further discussion on implementation challenges and suitable analytical techniques is provided.