Titlebook: Challenges in Protein Product Development; Nicholas W. Warne,Hanns-Christian Mahler Book 2018 American Association of Pharmaceutical Scien

FLIC

Analytical Characterization and Predictive Tools for Highly Concentrated Protein Formulationsracterization are discussed in detail and practical recommendation is given. Different common techniques to measure viscosity are described including dependencies on protein concentration, temperature, and shear stress. Structural characterization of highly concentrated protein formulations requires

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Practical Considerations for High Concentration Protein Formulationsuct. If potential candidates with impeding viscosity values are not identified early in development, subsequent mitigation efforts to reduce viscosity likely pivot from a protein engineering approach to changes in formulation.

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委屈

Container Closure Integrity Testing of Primary Containers for Parenteral Products are microbial challenge test, liquid tracer leak test, vacuum decay leak test, electrical conductivity leak test, tracer gas leak test, and headspace gas analyzer. Finally, the development, qualification, and validation of a method to be used are discussed. Each CCI test method has its advantages a

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Chemical Durability of Glass—Delaminationare discussed in detail as well as analytical techniques suited to investigate the impact on the properties of the primary packaging containers. The combination of the knowledge about the underlying root cause and the respective analytical tools to characterize the vial internal surfaces will help b

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2210-7371 tration,solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal o978-3-030-08052-5978-3-319-90603-4Series ISSN 2210-7371 Series E-ISSN 2210-738X

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Nonthreatening

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Randomized trial of fetal monitoringdose required for efficacy and patient-preferred self-administration through subcutaneous injection, which is oftentimes limited by dosing volume. Development of high-concentration protein products, however, has been associated with two major challenges—high solution viscosity and enhanced aggregati