Shulph Ink
Principles and Practices of Lyophilization in Product Development and Manufacturing
Principles and Practices of Lyophilization in Product Development and Manufacturing
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The biotechnology/biopharmaceutical sector has grown, leading to the invention of engineered antibodies such as ADC, BITES, DVD, and CART. This book covers the lyophilization process and product development and manufacturing, including an entire section on "Preservation of Biologicals" with case studies.
Format: Hardback
Length: 623 pages
Publication date: 25 April 2023
Publisher: Springer International Publishing AG
The biotechnology/biopharmaceutical sector has experienced remarkable growth, resulting in the development of innovative engineered antibodies like Antibody Drug Conjugates (ADCs), Bispecific T cell engager (BITES), Dual Variable Domain (DVD), Chimeric Antigen Receptor - Modified Tcells (CART), which are now being utilized as therapeutic agents for immunology and oncology disease conditions. These novel formats, alongside other pharmaceuticals and biopharmaceuticals, are delicate in terms of their stability/structure during processing, often requiring lyophilization to enhance their stability and shelf-life. This comprehensive book encompasses chapters/topics that delve into every aspect of the lyophilization process and product development and manufacturing, beginning with an overview of the lyophilization process, the equipment required, material characterization, formulation design, and lyophilization process development. It also covers various techniques for product characterization, scale-up/tech-transfer, and validation. Furthermore, the book discusses the application of Computational Fluid Dynamics (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 features an entire dedicated section on "Preservation of Biologicals," comprising nine chapters authored by experts and including case studies.
Weight: 1760g
Dimension: 216 x 287 x 43 (mm)
ISBN-13: 9783031126338
Edition number: 1st ed. 2023
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