Methods of high throughput biophysical characterization in biopharmaceutical development

Area of Science:

• Biopharmaceutical characterization
• Physical and chemical stability assessment
• High-throughput biophysical methods

Background:

• Biopharmaceutical product success relies on comprehensive molecular characterization.
• Assessing physical stability (chemical and structural) is vital for formulated biologics.
• Stability includes monitoring degradation and aggregation of proteins and peptides.

Purpose of the Study:

• To review high-throughput biophysical characterization techniques.
• To classify methods by their application in biopharmaceutical discovery, development, and manufacturing.
• To evaluate the current implementation status of these techniques.

Main Methods:

• Spectroscopic assays (absorbance, polarization, fluorescence).
• Surface Plasmon Resonance (SPR).
• Calorimetric methods, light scattering (dynamic and static), particle counting/sizing.
• Viscosity assays and mass spectrometry.

Main Results:

• Various high-throughput biophysical techniques are applicable across the biopharmaceutical lifecycle.
• Some methods are industrially implemented, while others are in early development or prototype stages.
• Techniques are evaluated based on their specific applications in biopharmaceutical development.

Conclusions:

• High-throughput biophysical characterization is essential for robust biopharmaceutical development.
• A range of techniques exists, with varying levels of industrial adoption.
• Continued development and implementation of these methods will enhance drug discovery and manufacturing.