ArticleFrontiers in chemistry2018
Detection of Collapse and Crystallization of Saccharide, Protein, and Mannitol Formulations by Optical Fibers in Lyophilization.
Article in Frontiers in chemistry, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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Who cites it
12 citing papers in PubMed.
- mRNA lipid nanoparticle vaccines: current status, challenges and future prospects.Molecular biomedicine · 2026Review
- Advances in Downstream Processing of Monoclonal Antibodies.Antibodies (Basel, Switzerland) · 2026Review
- Stabilization strategies and advancements in lyophilization to preserve integrity and efficacy of next-generation biologicals.International journal of pharmaceutics: X · 2026Review
- Colyophilized Sugar-Polymer Dispersions for Enhanced Processing and Storage Stability.Molecular pharmaceutics · 2024Article
- Lyoprotectant Constituents Suited for Lyophilization and Reconstitution of Stem-Cell-Derived Extracellular Vesicles.Biomaterials research · 2024Article
- Post-Processing Techniques for the Improvement of Liposome Stability.Pharmaceutics · 2021Review
- Lyophilization stabilizes clinical-stage core-crosslinked polymeric micelles to overcome cold chain supply challenges.Biotechnology journal · 2021Article
- Pharmaceutical protein solids: Drying technology, solid-state characterization and stability.Advanced drug delivery reviews · 2021Review
- Micro Freeze-Dryer and Infrared-Based PAT: Novel Tools for Primary Drying Design Space Determination of Freeze-Drying Processes.Pharmaceutical research · 2021Article
- Shelf-Life Extension of Fc-Fused Single Chain Fragment Variable Antibodies by Lyophilization.Frontiers in cellular and infection microbiology · 2021Article
- Be Aggressive! Amorphous Excipients Enabling Single-Step Freeze-Drying of Monoclonal Antibody Formulations.Pharmaceutics · 2019Article
- Effect of cellulose derivative matrix and oligosaccharide on the solid state and physical characteristics of dimethyldioctadecylammoniumliposomes for vaccine.Research in pharmaceutical sciences · 2019Article
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Authors and funding
2 authors.
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Abstract
The collapse temperature (Tc) and the glass transition temperature of freeze-concentrated solutions (Tg') as well as the crystallization behavior of excipients are important physicochemical characteristics which guide the cycle development in freeze-drying. The most frequently used methods to determine these values are differential scanning calorimetry (DSC) and freeze-drying microscopy (FDM). The objective of this study was to evaluate the optical fiber system (OFS) unit as alternative tool for the analysis of Tc, Tg' and crystallization events. The OFS unit was also tested as a potential online monitoring tool during freeze-drying. Freeze/thawing and freeze-drying experiments of sucrose, trehalose, stachyose, mannitol, and highly concentrated IgG1 and lysozyme solutions were carried out and monitored by the OFS. Comparative analyses were performed by DSC and FDM. OFS and FDM results correlated well. The crystallization behavior of mannitol could be monitored by the OFS during freeze/thawing as it can be done by DSC. Online monitoring of freeze-drying runs detected collapse of amorphous saccharide matrices. The OFS unit enabled the analysis of both Tc and crystallization processes, which is usually carried out by FDM and DSC. The OFS can hence be used as novel measuring device. Additionally, detection of these events during lyophilization facilitates online-monitoring. Thus the OFS is a new beneficial tool for the development and monitoring of freeze-drying processes.
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