Lyophilisation of proteins

Kapadia, Pradeep; Kannan, Aditi
February 2006
Chemical Business;Feb2006, Vol. 20 Issue 2, p33
Trade Publication
Freeze-drying or Lyophilisation mainly of pharmaceutical proteins is often the only processing method that provides requisite long term product stability for distribution and storage. However, freezing and drying can cause acute damage to proteins leading to degradation due to which the freeze dried product is not always perfectly stable. To alleviate damage, formulations frequently include protein stabilizers (often polymers and/or sugars) as well as buffering salts and inert bulking agents. This article discusses various parameters involved in freeze-drying of proteins and their stability in the final product. These parameters include process temperature, pH, combination of excipients and their concentration and storage conditions.


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