Application of novel techniques for characterization of subvisible and sub-micron particles in biopharmaceutical preparations

A large number of protein-based medicines have successfully improved the treatment and quality life of patients in diverse therapeutic areas. From a pharmaceutical technology perspective, the main associated implications are high viscosity and increased protein aggregation tendency that typically characterize protein formulations. Despite the proven safety and efficacy of biotechnological products, some publications have suggested that the particulate matter present in liquid formulations has immunogenic properties. Thus, there is an increasing interest to research and characterize protein particles beyond the limits of current USP applications of Chapter <787> had appeared in the recent years. A number of analytical techniques have emerged for the characterization of particles size between the upper size limit of chromatography techniques and the lower size limit of the compendial light obscuration method. Although this represents an instrumentation achievement, the analytical performance of such tools is unknown. This present Doctoral research aims to evaluate the applicability of the new techniques in the analysis of biotechnological products including deeper understanding of their principles as well as the comparative evaluation with the compendial light obscuration method.

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