Stabilizers and their interaction with formulation components in frozen and freeze-dried protein formulations

Seema Thakral, Jayesh Sonje, Bhushan Munjal, Raj Suryanarayanan

Research output: Contribution to journalReview articlepeer-review

57 Scopus citations


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 languageEnglish (US)
Pages (from-to)1-19
Number of pages19
JournalAdvanced Drug Delivery Reviews
Early online dateMar 17 2021
StatePublished - Jun 2021

Bibliographical note

Publisher Copyright:
© 2021 Elsevier B.V.


  • Aggregation
  • Cryoprotectants
  • Freeze-drying
  • Frozen storage
  • Lyoprotecants
  • Protein formulation
  • Stabilizers


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