Titlebook: Lyophilization of Pharmaceuticals and Biologicals; New Technologies and Kevin R. Ward,Paul Matejtschuk Book 2019 Springer Science+Business

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Formulation and Process Development for Lyophilized Biological Reference Materials, the lyophilization of a wide range of biological reference materials, many prepared as part of our work on behalf of the WHO, to develop freeze-dried reference materials to assign biological activity. These can cover a wide range of materials, often purified proteins and sera but also including nuc

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,Controlled Ice Nucleation Using ControLyo® Pressurization-Depressurization Method,nt past. Different Controlled Ice Nucleation (CIN) techniques investigated in the pharmaceutical industry are discussed in this chapter, along with their limitations for commercial implementation. Recent work using the ControLyo. pressurization and depressurization technology is further discussed, a

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Regulatory Aspects of Freeze-Drying,ibodies, and other biological materials, for improving their long-term stability. For biological products whose storage in aqueous solution results in instability, freeze-drying prolongs the shelf-life by inhibiting chemical, physical, and microbiological pathways that occur in the presence of moist

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Through Vial Impedance Spectroscopy (TVIS): A Novel Approach to Process Understanding for Freeze-Drch exploits the changes in the bulk electrical properties that occur on freezing and subsequent drying of a drug solution. Unlike the majority of uses of impedance spectroscopy, for freeze-drying process development, the electrodes do not contact the product but are attached to the outside of the gl