Biophysical Characterization of Biologics

Biophysical characterization of biologics is an essential step in the development and approval of these complex molecules. Biologics are large, structurally complex molecules produced by living organisms, such as proteins, antibodies, nucleic acids, and vaccines. These molecules can be sensitive to changes in their physical and chemical properties, which can affect their safety, efficacy, and stability.

Biophysical characterization techniques are used to assess the structural integrity, stability, and purity of biologics. These techniques include spectroscopy (such as UV-Vis, fluorescence, and circular dichroism), mass spectrometry, chromatography (such as size-exclusion chromatography and high-performance liquid chromatography), and thermal analysis (such as differential scanning calorimetry and thermal denaturation).

By using these techniques, scientists can determine important characteristics of biologics, such as their secondary and tertiary structure, aggregation state, binding affinity, and thermal stability. This information is crucial for ensuring the quality, safety, and efficacy of biologics throughout their development, manufacturing, and storage.

Overall, biophysical characterization plays a critical role in the development and regulation of biologics, helping to ensure that these complex molecules are safe and effective for use in patients.