Abstract
Biophysical techniques are essential tools in the development and characterization of biotherapeutics. The information gleaned from these techniques about the (higher-order) structure of the molecule provides insight into its behavior as process and formulation conditions are changed, thus helping to identify the optimum conditions for the molecule. Apart from their direct utilization in structural analysis, these techniques are can also be utilized in novel ways to assess comparability and troubleshooting product or process impact (e.g., elucidate aggregation mechanism, or assess aggregation propensity). Combinations of the methods are often required to answer any given question due to the complementary information the methods provide. Case studies involving the use of circular dichroism, differential scanning calorimetry, dynamic light scattering, analytical ultracentrifugation (sedimentation velocity and gravity sweep), isothermal titration calorimetry, intrinsic fluorescence, and extrinsic (steady-state, thermal-scanning, and stopped-flow) fluorescence have been provided.
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Singh, S.K., Zou, Q., Huang, M., Bilikallahalli, M. (2013). Application of Biophysics in Formulation, Process, and Product Characterization: Selected Case Studies. In: Narhi, L. (eds) Biophysics for Therapeutic Protein Development. Biophysics for the Life Sciences, vol 4. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-4316-2_7
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DOI: https://doi.org/10.1007/978-1-4614-4316-2_7
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