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Process Analytical Technology (PAT) for Lyophilization Process Monitoring and End Point Detection
Process analytical technology (PAT) is critical during freeze drying at extreme conditions (low temperature and low pressure), and latest PAT tools...
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Challenges and Considerations in the Development of a High Protein Concentration Lyophilized Drug Product
The lyophilized high concentration protein drug products have the advantages of product stability suitable for ADC and other stability sensitive...
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Chapter 14: Practical Considerations in High Concentration Formulation Development for Monoclonal Antibody Drug Products
This book chapter covers practical consideration and strategies in developing high concentration formulations and drug products for commercial use....
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Measurement of the Kinetics of Protein Unfolding in Viscous Systems and Implications for Protein Stability in Freeze-Drying
PurposeThe aim of the study is to determine the degree of coupling between protein unfolding rate and system viscosity at low temperatures in systems...
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The Effect of Stabilizers and Denaturants on the Cold Denaturation Temperatures of Proteins and Implications for Freeze-Drying
PurposeThe aim of the study is to investigate the effects of stabilizers and denaturants on the thermal and cold denaturation temperatures of...
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Freeze-Drying Process Design by Manometric Temperature Measurement: Design of a Smart Freeze-Dryer
Purpose.To develop a procedure based on manometric temperature measurement (MTM) and an “expert system” for good practices in freeze drying that will...
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Design of Freeze-Drying Processes for Pharmaceuticals: Practical Advice
Design of freeze-drying processes is often approached with a “trial and error” experimental plan or, worse yet, the protocol used in the first...