Review Of Analytical Techniques For Assessing Quality Attributes Of Therapeutic Proteins

By Małgorzata URBANIAK, Senior Specialist in Physicochemical Analytical Methods, Mabion S.A.

This white paper offers an in-depth evaluation of the analytical techniques indispensable for assessing the critical quality attributes (CQAs) of therapeutic proteins. It meticulously details the inherent advantages and limitations of each technique, providing a balanced perspective on their utility. This comprehensive assessment is not merely theoretical; it is firmly anchored in the most current scientific knowledge available in published literature and rigorously adheres to the prevailing regulatory guidelines that govern the biopharmaceutical landscape.

Beyond a general overview, the author specifically illuminates Mabion's strategic framework for the judicious selection and application of these analytical methods. This framework is crucial for thoroughly evaluating the diverse quality attributes across its various research and development projects. A key emphasis is placed on the critical factors that must be carefully considered when customizing an analytical panel. This tailoring process is highly individualized, taking into account the unique physicochemical characteristics of a given therapeutic molecule and the specific developmental phase of the project.

Furthermore, by downloading the white paper below, readers will uncover the importance of employing complementary and orthogonal methods. This multi-faceted approach ensures a more comprehensive characterization of the therapeutic product and provides a robust mechanism for verifying results obtained through disparate analytical avenues, thereby enhancing the reliability and trustworthiness of the data.