Development of Stable Lyophilized Protein Drug Products

Title: Development of Stable Lyophilized Protein Drug Products

Volume: 13 Issue: 3

Author(s): Richard L. Remmele, Sampathkumar Krishnan and William J. Callahan

Affiliation:

Keywords: Analytical methods, biopharmaceuticals, excipients, lyophilization, labile molecules, physical properties, lyophilization cycle development, protein product stability, degradation pathways, drug product, Glass transition temperatures, lyophilized state, active pharmaceutical ingredient (API), solid phase parameters, proteins

Abstract: Freeze drying, or lyophilization is widely used for biopharmaceuticals to improve the long term storage stability of labile molecules. This review examines general theory and practice of rational lyophilization of biopharmaceuticals. Formulation development involving the selection of appropriate excipients, their associated physical properties, and mechanism of action in achieving a stable drug product are primary considerations for a successful lyophilization program. There are several parameters considered critical on the basis of their relationship to lyophilization cycle development and protein product stability. This along with the importance of analytical methods to provide insight toward understanding properties of drug product stability and cake structure are discussed. Also, aspects of instability found in lyophilized biopharmaceutical products, their degradation pathways and control are elucidated. Finally, container-closure requirements and drug product handling are described in context of the caveats to avoid compromising drug product quality.

Cite this article as:

L. Remmele Richard, Krishnan Sampathkumar and J. Callahan William, Development of Stable Lyophilized Protein Drug Products, Current Pharmaceutical Biotechnology 2012; 13 (3) . https://dx.doi.org/10.2174/138920112799361990