Principles and Practices of Lyophilization in Product Development and Manufacturing

Language: English

Published by Springer, Springer Apr 2024, 2024

303112636X / 9783031126369

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This item is printed on demand - Print on Demand Titel. Neuware -The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T cell engager ( BITES), Dual Variable Domain ( DVD), Chimeric Antigen Receptor - Modified Tcells (CART) that are currently being used as therapeutic agents for immunology and oncology disease conditions. In addition to other pharmaceuticals and biopharmaceuticals, all these novel formats are fragile with respect to their stability/structure under processing conditions meaning marginal stability in the liquid state and often require lyophilization to enhance their stability and shelf-life. This book contains chapters/topics that will describe every aspect of the lyophilization process and product development and manufacturing starting from the overview of lyophilization process, equipment required, characterization of the material, design and development of the formulation and lyophilization process, various techniques for characterization of the product, scale-up/tech-transfer and validation. It also describes the application of CFD coupled with mathematical modeling in the lyophilization process and product development, scale-up, and manufacturing. Additionally, Principles and Practice of Lyophilization Process and Product Development contains an entire dedicated section on 'Preservation of Biologicals' comprised of nine chapters written by experts and including case studies.Springer-Verlag KG, Sachsenplatz 4-6, 1201 Wien 640 pp. Englisch.

Seller Inventory # 9783031126369

Title
Principles and Practices of Lyophilization in Product Development and Manufacturing
Author
Feroz Jameel
Publisher
Springer, Springer Apr 2024
Publication year
2024
Condition
Neu
Binding
Taschenbuch
Language
English
ISBN 10
303112636X
ISBN 13
9783031126369
Item weight
1,535 grams
Dimensions
279x210x35 mm

buchversandmimpf2000

Emtmannsberg, BAYE, Germany

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