Adjustment of specific residual moisture levels in completely freeze-dried protein formulations by controlled spiking of small water volumes
Author:
Publisher
Elsevier BV
Subject
Pharmaceutical Science,General Medicine,Biotechnology
Reference11 articles.
1. Effect of Moisture on the Stability of a Lyophilized Humanized Monoclonal Antibody Formulation;Breen;Pharm. Res.,2001
2. The Role of Moisture in Protein Stability;Hageman;Drug Dev. Ind. Pharm.,1988
3. Effect of Water on the Chemical Stability of Amorphous Pharmaceuticals: 2. Deamidation of Peptides and Proteins;Ohtake;J. Pharm. Sci.,2018
4. Water Distribution and Clustering on the Lyophilized IgG1 Surface: Insight from Molecular Dynamics Simulations;Feng;Mol. Pharm.,2020
5. Determining the optimum residual moisture in lyophilized protein pharmaceuticals;Hsu;Dev. Biol. Stand.,1992
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