Principles and Practices of Lyophilization in Product Development and Manufacturing (AAPS Advances in the Pharmaceutical Sciences Series, 59) (PDF)

Name: Principles and Practices of Lyophilization in Product Development and Manufacturing (AAPS Advances in the Pharmaceutical Sciences Series, 59) (PDF)
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This book is about the lyophilization process used in the development and manufacturing of biopharmaceuticals, including engineered antibodies. It covers topics such as equipment, formulation, characterization, scale-up, tech-transfer, and validation, as well as the application of CFD and mathematical modeling. It also includes a dedicated section on the preservation of biologicals. The book is published by Springer, is written in English, and is 636 pages long. The ISBN-10 is 3031126335 and the ISBN-13 is 978-3031126338.

Category: Springer Ebook

Description

Principles and Practices of Lyophilization in Product Development and Manufacturing (AAPS Advances in the Pharmaceutical Sciences Series, 59) (PDF Book)

Lyophilization Process and Product Development for Biopharmaceuticals

Written by Feroz Jameel, this book discusses the rapid growth of the biotechnology/biopharmaceutical industry that led to the development of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T cell engager ( BITES), Dual Variable Domain ( DVD), and Chimeric Antigen Receptor – Modified Tcells (CART), which are used as therapeutic agents for a variety of immune and oncology conditions. However, these novel formats are fragile and require lyophilization to enhance their stability and shelf-life. This book covers all aspects of the lyophilization process and product development for these biopharmaceuticals.