An accelerated antibody aggregation test based on time sequenced dynamic light scattering

An accelerated antibody aggregation test based on time sequenced dynamic light scattering
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基于时间序列动态光散射的加速抗体聚集测试

DOI:
10.1016/j.colsurfa.2022.129833
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发表时间:
2022
期刊:
Colloids and Surfaces A: Physicochemical and Engineering Aspects
影响因子:
--
通讯作者:
Velev, Orlin D.
Velev, Orlin D.
中科院分区:
--
文献类型:
--
作者:
Conner, Cathryn G.;McAndrew, James;Menegatti, Stefano;Velev, Orlin D.

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A rapid method for determination of the colloidal stability of protein molecules in solution is reported as an efficient tool for evaluating the stability of antibody formulations. Using human polyclonal immunoglobulin G (IgG) as a model protein and dynamic light scattering (DLS) as a technique to determine the size of particles in solution, the rate of aggregation is investigated at different temperatures and antibody concentrations. To reduce the observation period while increasing precision, a new approach to DLS analysis is developed that comprises: (i) a distribution analysis of high-resolution data, and fitting for multiple particle sizes present in a solution, (ii) a temperature ramp to an intermediate temperature followed by a stress test at constant temperature over several hours, and (iii) 3-D plotting to reveal the time-dependent evolution of the particle size distribution at the selected temperature. The resulting 3-D plots enable robust identification of the onset of aggregation with different dispersion conditions. This method enables rapid evaluation of the effects of parameters such as temperature and concentration on the stability of antibody solutions.
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