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Journal ArticleDOI

Freeze‐dry microscopy of protein/sugar mixtures: Drying behavior, interpretation of collapse temperatures and a comparison to corresponding glass transition Data

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TLDR
Application of the Gordon-Taylor equation failed to predict the critical temperature for any of the protein/sugar mixtures studied, and V(sub) was found to correlate with the measured collapse temperature which could be used to qualitatively investigate the product resistance to water vapor flow.
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This article is published in Journal of Pharmaceutical Sciences.The article was published on 2009-09-01. It has received 106 citations till now. The article focuses on the topics: Low protein & Differential scanning calorimetry.

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Journal ArticleDOI

Recent advances and further challenges in lyophilization.

TL;DR: The dogma of "never lyophilize above the glass transition temperature" is argued, and recent insights into novel stabilization concepts are provided.
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Freeze-drying of emulsified systems: A review.

TL;DR: The lyophilized products are very stable and are easy to transport and store, and the mechanism of cryoprotection and the techniques that can be used to characterize the freeze-dried systems are discussed.
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The Importance of Understanding the Freezing Step and Its Impact on Freeze-Drying Process Performance

TL;DR: The aim of the current review is to gather existing information on the physicochemical phenomena involved in the freezing process and how these phenomena impact the subsequent drying step of the freeze-drying process.
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Freeze-Drying Above the Glass Transition Temperature in Amorphous Protein Formulations While Maintaining Product Quality and Improving Process Efficiency

TL;DR: Drying amorphous formulations above Tg′, particularly high protein concentration formulations, is a viable means to achieve significant time and cost savings in freeze-drying processes.
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Freeze-drying of proteins with glass-forming oligosaccharide-derived sugar alcohols.

TL;DR: The glass-forming sugar alcohols showed lower susceptibility to Maillard reaction with co-lyophilized L-lysine compared to reducing and non-reducing disaccharides during storage at elevated temperature.
References
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Book

Lange's Handbook of Chemistry

TL;DR: This encyclopedic work includes authoritative coverage of atomic and molecular structure, organic chemistry (revised), inorganic, analytical, and electro- chemistry, mathematics as applied to chemistry, and more.
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Characteristics and Significance of the Amorphous State in Pharmaceutical Systems

TL;DR: The amorphous state is critical in determining the solid-state physical and chemical properties of many pharmaceutical dosage forms and some of the most common methods that can be used to measure them are described.
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Lyophilization and development of solid protein pharmaceuticals

TL;DR: Four interrelated topics are discussed: lyophilization and its denaturation stresses, cryo- and lyo-protection of proteins by excipients, design of a robust lyophILization cycle, and with emphasis, instability, stabilization, and formulation of solid protein pharmaceuticals.
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Elastic Behavior of Cross-Linked and Bundled Actin Networks

TL;DR: It is shown that networks of cross-linked and bundled actin filaments exhibit exceptional elastic behavior that reflects the mechanical properties of individual filaments, and parameterize the full range of behavior in a state diagram and elucidate its origin with a robust model.
Journal ArticleDOI

Antibody structure, instability, and formulation

TL;DR: The structure and function of antibodies and the mechanisms of physical and chemical instabilities are reviewed and various aspects of formulation development have been examined to identify the critical attributes for the stabilization of antibodies.
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