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Endonuclease-like activity of heme proteins
Heme proteins, metmyoglobin, methemoglobin, and metcytochrome c showed unusual affinity for double-stranded DNA. Calorimetric studies show that binding of methemoglobin to calf thymus DNA (CTDNA) is weakly endoth...
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Process Scale-Up and Optimization of Lyophilized Vaccine Products
Vaccine, in general, is our best defense against infectious diseases and represents one of the greatest success stories responsible for the reduction of infectious diseases. Relative to therapeutic proteins (T...
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Chapter 7: An Empirical Phase Diagram: High-Throughput Screening Approach to the Characterization and Formulation of Biopharmaceuticals
The complexity of proteins usually requires the use of multiple, moderate resolution experimental techniques to provide an information-rich picture of their structure and stability. Here we describe a techniqu...
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Open AccessEvaluation of Microwave Vacuum Drying as an Alternative to Freeze-Drying of Biologics and Vaccines: the Power of Simple Modeling to Identify a Mechanism for Faster Drying Times Achieved with Microwave
Vial-based lyophilization for biopharmaceuticals has been an indispensable cornerstone process for over 50 years. However, the process is not without significant challenges. Capital costs to realize a lyophili...
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Flexible Manufacturing: The Future State of Drug Product Development and Commercialization in the Pharmaceutical Industry
Flexible manufacturing systems are needed in the pharmaceutical industry due to the future challenges of volatility, uncertainty, complexity, and ambiguity [1]. Compared to traditional manufacturing systems that ...
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Open AccessRecommended Best Practices for Lyophilization Validation—2021 Part I: Process Design and Modeling
This work describes lyophilization process validation and consists of two parts. Part I focuses on the process design and is described in the current paper, while part II is devoted to process qualification an...
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Correction to: Recommended Best Practices for Lyophilization Validation—2021 Part I: Process Design and Modeling
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Open AccessRecommended Best Practices for Lyophilization Validation 2021 Part II: Process Qualification and Continued Process Verification
This work describes the lyophilization process validation and consists of two parts. Part one (Part I: Process Design and Modeling) focuses on the process design and is described in the previous paper, while t...
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A Software Tool for Lyophilization Primary Drying Process Development and Scale-up Including Process Heterogeneity, I: Laboratory-Scale Model Testing
Freeze-drying is a deceptively complex operation requiring sophisticated design of a robust and efficient process that includes understanding and planning for heterogeneity across the batch and shifts in param...
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Chapter
Lyophilization Validation: Process Design and Modeling
This work describes lyophilization process validation and consists of two parts. Part one focuses on the process design and is described in the current paper, while part two is devoted to process qualification...
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Chapter
Lyophilization Validation: Process Qualification and Continued Process Verification
This work describes the lyophilization process validation and consists of two parts. Part I (Part I: Process Design and Modeling) focuses on the process design and is described in the previous paper, while the...
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Assessing Antigen-Adjuvant Complex Stability Against Physical Stresses By wNMR
This study applies an emerging analytical technology, wNMR (water proton nuclear magnetic resonance), to assess the stability of aluminum adjuvants and antigen-adjuvant complexes against physical stresses, includ...
