Biophysical Testing
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Biophysical characterization provides direct insight into the structure and physical properties of therapeutic proteins. CovalX offers a suite of orthogonal spectroscopic and calorimetric methods to support protein characterization at any stage of development, from early candidate assessment to regulatory submission.
Structural and Physical Characterization of Therapeutic Proteins
Establishing the secondary structure, conformational integrity, and thermal stability of a biopharmaceutical is a core requirement of physicochemical characterization programs. These analyses are directly referenced in ICH Q6B guidelines and are expected by FDA and EMA as part of IND and BLA submissions. CD, FTIR, UV-Vis, and DSC are recognized methods for assessing secondary structure, thermal stability, and physical integrity within this framework.
Techniques
Circular Dichroism (CD)
CD uses differential absorption of circularly polarized light to assess conformational integrity and support comparability studies.
Fourier Transform Infrared Spectroscopy (FTIR)
Through amide I band analysis, FTIR characterizes secondary structure in solution.
Ultraviolet and Visible Absorption Spectroscopy (UV-Vis)
UV-Vis determines absorbance profiles and detects aggregates and chromophoric impurities relevant to product quality assessment.