An Investigation Into The Thermal And Analytical Techniques Used In The Development Of Lyophilised Protein Pharmaceuticals
Source: Biopharma Technology Limited
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•Case Study: An Investigation Into The Thermal And Analytical Techniques Used In The Development Of Lyophilised Protein Pharmaceuticals
Freeze-drying (lyophilisation) is a unit operation in which a solvent, usually water, is frozen and then sublimed in a vacuum. It is commonly used in the pharmaceutical industry when there are stability issues with the active ingredient in solution, as is often true for proteins. In order to prevent processing defects during freeze-drying, active ingredients are formulated with excipients, which may serve specific functions, such as providing bulk properties, thermal stability and activity preservation to the product. Many groups of molecules have been shown to perform these functions, including disaccharides, amino acids, polymers and non-ionic surfactants. The aim of this study was to evaluate the correlation between the different analysis methods based on pre- and postlyophilisation properties of a range of proteinexcipient mixtures. Success of these mixtures were based on retained protein activity. Downloads:
•Case Study: An Investigation Into The Thermal And Analytical Techniques Used In The Development Of Lyophilised Protein Pharmaceuticals
•Case Study: An Investigation Into The Thermal And Analytical Techniques Used In The Development Of Lyophilised Protein Pharmaceuticals
Freeze-drying (lyophilisation) is a unit operation in which a solvent, usually water, is frozen and then sublimed in a vacuum. It is commonly used in the pharmaceutical industry when there are stability issues with the active ingredient in solution, as is often true for proteins. In order to prevent processing defects during freeze-drying, active ingredients are formulated with excipients, which may serve specific functions, such as providing bulk properties, thermal stability and activity preservation to the product. Many groups of molecules have been shown to perform these functions, including disaccharides, amino acids, polymers and non-ionic surfactants. The aim of this study was to evaluate the correlation between the different analysis methods based on pre- and postlyophilisation properties of a range of proteinexcipient mixtures. Success of these mixtures were based on retained protein activity. Downloads:
•Case Study: An Investigation Into The Thermal And Analytical Techniques Used In The Development Of Lyophilised Protein Pharmaceuticals