Banner image for CovalX epitope mapping services showing a 3D molecular surface model of an antibody-antigen interaction de novo sequencing
Epitope Mapping Service CovalX provides epitope mapping services using XL-MS and HDX-MS to characterize antibody binding sites and protein-protein interactions at the peptide level.

Biophysical Testing

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Biophysical instrument setup with data analysis software for protein characterization in support of ICH Q6B regulatory submissions Biophysical testing services CovalX provides biophysical testing services for protein and antibody characterization, supporting ICH Q6B regulatory submissions and biologics development.
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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

Differential Scanning Calorimetry (DSC)

DSC measures thermal stability parameters to support formulation optimization and biosimilarity studies.

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.
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