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Thermal denaturation evaluation service for antibody pharmaceuticals (Raman spectroscopy and secondary structure analysis)

Visualizing the thermal denaturation of antibody drugs using Raman spectroscopy. Non-destructive and quantitative evaluation of secondary structure changes.

Antibody pharmaceuticals can undergo changes in their higher-order structure due to factors such as thermal stress, storage conditions, and manufacturing processes, which may affect their quality and efficacy. Tech Analysis Co., Ltd. combines Raman spectroscopy with waveform separation analysis in the Amide I region to evaluate changes in the secondary structure of antibody pharmaceuticals in a non-destructive and non-invasive manner. Evaluations using trastuzumab, infliximab, and bevacizumab confirmed different thermal denaturation behaviors for each antibody pharmaceutical. Additionally, it has been confirmed that subtle structural changes occurring before rapid thermal denaturation can also be visualized. This service can be utilized by customers considering quality evaluation of antibody pharmaceuticals, thermal stability assessment, examination of manufacturing conditions, evaluation of storage conditions, research and development, and applications in PAT (Process Analytical Technology).