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)|
|Number of pages||19|
|Journal||Advanced Drug Delivery Reviews|
|Early online date||Mar 17 2021|
|State||Published - Jun 2021|
Bibliographical notePublisher Copyright:
© 2021 Elsevier B.V.
- Frozen storage
- Protein formulation
PubMed: MeSH publication types
- Journal Article