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Updated: Jul 19, 2025

Mass Spectrometric Approaches to Study Protein Structure and Interactions in Lyophilized Powders
Published on: April 14, 2015
Application of Formulation Principles to Stability Issues Encountered During Processing, Manufacturing, and Storage
Samadhi Vitharana1, Joshua M Stillahn2, Derrick S Katayama3
1Technical Consultant, Biologics CMC, San Diego, CA, USA.
Abstract:
The field of formulation and stabilization of protein therapeutics has become rather extensive. However, most of the focus has been on stabilization of the final drug product. Yet, proteins experience stress and degradation through the manufacturing process, starting with fermentaition. This review describes how formulation principles can be applied to stabilize biopharmaceutical proteins during bioprocessing and manufacturing, considering each unit operation involved in prepration of the drug substance. In addition, the impact of the container on stabilty is discussed as well.
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