Effects of Excipient Interactions on the State of the Freeze-Concentrate and Protein Stability

[1] Chatterjee K(2005)Partially crystalline systems in lyophilization: II. Withstanding collapse at high primary drying temperatures and impact on protein activity recovery J Pharm Sci 94 809-820

[2] Shalaev EY(2005)Partially crystalline systems in lyophilization: I. Use of ternary state diagrams to determine extent of crystallization of bulking agent J Pharm Sci 94 798-808

[3] Suryanarayanan R(1993)Decreased protein-stabilizing effects of cryoprotectants due to crystallization Pharm Res 10 1232-1237

[4] Chatterjee K(1991)The effects of additives on the stability of freeze-dried β-galactosidase stored at elevated temperature Int J Pharm 71 137-146

[5] Shalaev EY(2002)Mannitol–sucrose mixtures—versatile formulations for protein lyophilization J Pharm Sci 91 914-922

[6] Suryanarayanan R(2004)Effect of collapse on the stability of freeze‐dried recombinant factor VIII and α‐amylase J Pharm Sci 93 1253-1263

[7] K-i I(1998)The role of vitrification in anhydrobiosis Annu Rev Physiol 60 73-103

[8] Yoshioka S(2001)The trehalose myth revisited: introduction to a symposium on stabilization of cells in the dry state Cryobiology 43 89-105

[9] Terao T(2004)Effect of aging on the physical properties of amorphous trehalose Pharm Res 21 867-874

[10] Ken-ichi I(2004)Effect of preparation method on physical properties of amorphous trehalose Pharm Res 21 1167-1176

[1] Chatterjee K(2005)Partially crystalline systems in lyophilization: II. Withstanding collapse at high primary drying temperatures and impact on protein activity recovery J Pharm Sci 94 809-820

[2] Shalaev EY(2005)Partially crystalline systems in lyophilization: I. Use of ternary state diagrams to determine extent of crystallization of bulking agent J Pharm Sci 94 798-808

[3] Suryanarayanan R(1993)Decreased protein-stabilizing effects of cryoprotectants due to crystallization Pharm Res 10 1232-1237

[4] Chatterjee K(1991)The effects of additives on the stability of freeze-dried β-galactosidase stored at elevated temperature Int J Pharm 71 137-146

[5] Shalaev EY(2002)Mannitol–sucrose mixtures—versatile formulations for protein lyophilization J Pharm Sci 91 914-922

[6] Suryanarayanan R(2004)Effect of collapse on the stability of freeze‐dried recombinant factor VIII and α‐amylase J Pharm Sci 93 1253-1263

[7] K-i I(1998)The role of vitrification in anhydrobiosis Annu Rev Physiol 60 73-103

[8] Yoshioka S(2001)The trehalose myth revisited: introduction to a symposium on stabilization of cells in the dry state Cryobiology 43 89-105

[9] Terao T(2004)Effect of aging on the physical properties of amorphous trehalose Pharm Res 21 867-874

[10] Ken-ichi I(2004)Effect of preparation method on physical properties of amorphous trehalose Pharm Res 21 1167-1176