Name: Principles and Practices of Lyophilization in Product Development and Manufacturing (en Inglés)
SKU: 57580374
Price: 2928.87 MXN
Availability: InStock
Author: Jameel, Feroz
ISBN: 9783031126369

portada Principles and Practices of Lyophilization in Product Development and Manufacturing (en Inglés)

Principles and Practices of Lyophilization in Product Development and Manufacturing (en Inglés)

Formato

Libro Físico

Editorial

Springer

Autor

Jameel, Feroz

Idioma

Inglés

N° páginas

623

Encuadernación

Tapa Blanda

ISBN13

9783031126369

Categorías

Farmacología
Farmacia/prescripción/dispensación
Química orgánica

Principles and Practices of Lyophilization in Product Development and Manufacturing (en Inglés)

Jameel, Feroz (Autor) · Springer · Tapa Blanda

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Reseña del libro "Principles and Practices of Lyophilization in Product Development and Manufacturing (en Inglés)"

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.