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).
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basic information
【Evaluation Targets】 - Antibody drugs - Protein preparations - Biopharmaceuticals 【Evaluation Methods】 - Raman spectroscopy - Amide I region analysis - Waveform separation analysis - Peak area ratio analysis 【Measurement Methods】 - Liquid immersion Raman probe - Non-destructive measurement - Non-invasive measurement 【Evaluation Items】 - Thermal stability evaluation - Secondary structure changes - Quantitative evaluation of structural changes - Comparison of thermal denaturation behavior
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Applications/Examples of results
- Evaluation of thermal stability of antibody drugs - Comparative evaluation during manufacturing process changes - Consideration of storage conditions - Formulation development - Quality evaluation - Consideration of PAT (Process Analytical Technology) implementation - Research and development of biopharmaceuticals - Structural change analysis using Raman spectroscopy
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Thermal denaturation evaluation service for antibody pharmaceuticals (Raman spectroscopy and secondary structure analysis)
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Company information
Our company supports the establishment of measurement methods, analytical techniques, and testing methods (analytical methods) using Raman spectroscopy, centered on vibrational spectroscopy, which can be utilized in quality control areas such as acceptance testing, from research and development fields like the evaluation of the physical properties of pharmaceutical raw materials and the dispersion state of solid formulation particles. We provide support for the development of analytical conditions, testing method settings, and validation. Please feel free to contact us if you have any requests.
