Written by experienced authorities in process validation, Process Validation in Manufacturing of Biopharmaceuticals explores current trends in the field and strategies for the selection of the most appropriate quality control scheme. It offers practical guidelines, recommendations, and an abundance of industrial case studies that demonstrate various techniques and approaches in the validation of biopharmaceutical processes.
Provides specific examples of failure modes and effect analysis (FMEA) that help you establish this method in your organization
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Zustand: Sehr gut. Zustand: Sehr gut | Seiten: 600 | Sprache: Englisch | Produktart: Bücher | Written by top authorities in process validation, this reference explores current trends in the field and strategies for selecting the most appropriate quality control scheme. It offers practical guidelines, recommendations, and an abundance of case studies that showcase various techniques and approaches in the validation of biopharmaceutical processes. These include guidance on determining the life spans of chromatography and filtration media, process characterization and techniques for scaling-down unit operations in biopharmaceutical manufacturing, examples of contamination events, and practical methods for testing raw materials and in-process samples during various manufacturing stages. Artikel-Nr. 2060906/2
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