研究论文
An Integrated Process Analytical Technology (PAT) Approach to Monitoring the Effect of Supercooling on Lyophilization Product and Process Parameters of Model Monoclonal Antibody Formulations
David Awotwe Otoo, Cyrus Agarabi, Mansoor A. Khan
United States Food and Drug Administration Quality Research
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学术脉络
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生物医学Protein purification and stability
Monoclonal and Polyclonal Antibodies Research · Viral Infectious Diseases and Gene Expression in Insects
参考文献 34
Effect of Moisture on the Stability of a Lyophilized Humanized Monoclonal Antibody Formulation
被引 195E. D. Breen, J. G. Curley, David E. Overcashier · Pharmaceutical Research · 2001
Evaluation of manometric temperature measurement as a method of monitoring product temperature during lyophilization.
被引 155Nathaniel Milton, Michael J. Pikal, Michael L. Roy · PubMed · 1997
Practical aspects of lyophilization using non-aqueous co-solvent systems
被引 187Dirk L. Teagarden, David S. Baker · European Journal of Pharmaceutical Sciences · 2002
此处列出前 3 条
引用本文 25
The Importance of Understanding the Freezing Step and Its Impact on Freeze-Drying Process Performance
被引 228Getachew Assegehegn, Edmundo Brito‐de la Fuente, J.M. Franco · Journal of Pharmaceutical Sciences · 2018
Science and art of protein formulation development
被引 107Wei Wang, Satoshi Ohtake · International Journal of Pharmaceutics · 2019
Freeze-Drying of l -Arginine/Sucrose-Based Protein Formulations, Part 2: Optimization of Formulation Design and Freeze-Drying Process Conditions for an l -Arginine Chloride-Based Protein Formulation System
被引 31Peter Stärtzel, Henning Gieseler, Margit Gieseler · Journal of Pharmaceutical Sciences · 2015
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