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Abstract
Therapeutic protein preparations are usually stored in a solid state to reduce the physical and chemical degradation by removing most of the solvent (mostly water) in liquid protein preparations, improving stability and maintaining biological activity. Freeze-drying (FD) is a common method to produce the dehydrated therapeutic protein. However, various induced stresses exist in the processing steps involved in FD, such as freezing process, primary drying, and secondary drying, may cause protein instability. To overcome this problem, two means are often employed: adding stabilizers to protect proteins from physical damage associated with the FD process; optimizing parameter conditions during the FD process to reduce protein degeneration. Therefore, a deep understanding of the protein preparation formula composition and FD process parameters is crucial for the development of stable therapeutic protein products. This study reviewed the stabilization mechanisms of protein during FD, focused on the factors that induce protein instability, and discussed the relationship between protein structure changes and instability, expected to provide references for solving the instability during protein freeze-drying and storage.
Acknowledgements
The authors thank Dr. Wenchao Liu and Dr. Linlin Li for writing and editorial assistance during the preparation of this manuscript.
Compliance with ethics guidelines
Zhe Wang, Linlin Li, Guangyue Ren, Xu Duan, Jingfang Guo, Wenchao Liu, Yuan Ang, Lewen Zhu, and Xing Ren declare that they have no conflict of interest. This article does not contain any studies with human or animal subjects performed by the any of the authors.