Abstract
This review aims to provide an overview of the current knowledge on protein stabilization during freezing and freeze-drying in relation to stress conditions commonly encountered during these processes. The traditional as well as refined mechanisms by which excipients may stabilize proteins are presented. These stabilizers encompass a wide variety of compounds including sugars, sugar alcohols, amino acids, surfactants, buffers and polymers. The rational selection of excipients for use in frozen and freeze-dried protein formulations is presented. Lyophilized protein formulations are generally multicomponent systems, providing numerous possibilities of excipient-excipient and protein-excipient interactions. The interplay of different formulation components on the protein stability and excipient functionality in the frozen and freeze-dried systems are reviewed, with discussion of representative examples of such interactions.
Original language | English (US) |
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Pages (from-to) | 1-19 |
Number of pages | 19 |
Journal | Advanced Drug Delivery Reviews |
Volume | 173 |
Early online date | Mar 17 2021 |
DOIs | |
State | Published - Jun 2021 |
Bibliographical note
Publisher Copyright:© 2021 Elsevier B.V.
Keywords
- Aggregation
- Cryoprotectants
- Freeze-drying
- Frozen storage
- Lyoprotecants
- Protein formulation
- Stabilizers