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

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

6 $

Format : Publisher PDF

File Size : 35.4 MB

Category:

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

By Feroz Jameel
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.

The biotechnology and biopharmaceutical sector has experienced a tremendous growth in recent years, leading to the development of innovative therapeutic agents for immunology and oncology diseases. One such advancement is the creation of engineered antibodies, including Antibody Drug Conjugates (ADCs), Bispecific T cell engager (BITES), Dual Variable Domain (DVD), and Chimeric Antigen Receptor-Modified T cells (CART). These novel formats offer promising treatment options but are also fragile and require lyophilization to enhance stability and extend shelf-life.

Principles and Practice of Lyophilization Process and Product Development is a comprehensive book that delves into every aspect of the lyophilization process and the development and manufacturing of products. The book covers a wide range of topics, starting with an overview of the lyophilization process and the equipment required. It then explores the characterization of the material, formulation and lyophilization process design and development, various techniques for product characterization, scale-up, tech-transfer, and validation. The use of computational fluid dynamics (CFD) coupled with mathematical modeling in the lyophilization process and product development is also discussed.

The book also includes a dedicated section on “Preservation of Biologicals,” which consists of nine chapters written by experts in the field. These chapters provide valuable insights and case studies on the preservation of biological substances.

Product Details

  • Publisher: Springer; 1st ed. 2023 edition (April 25, 2023)
  • Language: English
  • Pages: 636
  • ISBN-10: 3031126335
  • ISBN-13: 978-3031126338

Introduction

Principles and Practice of Lyophilization Process and Product Development is a highly informative and comprehensive guide that aims to equip readers with a thorough understanding of the lyophilization process and its applications in the biotechnology and biopharmaceutical industries.

The book is authored by Feroz Jameel, an expert in the field, who brings extensive knowledge and experience to the topic. Jameel takes readers on a journey, starting with the fundamentals of lyophilization and gradually diving into advanced concepts and techniques. The book is suitable for professionals in the biopharmaceutical industry, including researchers, scientists, engineers, and manufacturing professionals, as well as students and academia interested in gaining a deeper understanding of lyophilization and its applications.

Review

Principles and Practice of Lyophilization Process and Product Development has received rave reviews from industry experts and professionals. The book is highly regarded for its comprehensive coverage of the lyophilization process and its practical applications. Readers have praised the author’s ability to present complex concepts in a clear and concise manner, making it accessible to both experts and newcomers in the field.

The book is not only informative but also highly practical. It provides step-by-step guidance on the development and manufacturing of lyophilized products, from characterization and formulation to scale-up and validation. The inclusion of case studies further enhances the practicality of the book and allows readers to apply the knowledge gained to real-world scenarios.

Readers have also appreciated the dedicated section on “Preservation of Biologicals,” which addresses the unique challenges of preserving biological substances. The inclusion of case studies in this section provides valuable insights into best practices and real-life examples of successful preservation techniques.

Order Now

If you are involved in the biotechnology or biopharmaceutical industry or are a student or researcher interested in gaining a comprehensive understanding of the lyophilization process, Principles and Practice of Lyophilization Process and Product Development is a must-read. This book will equip you with the knowledge and skills necessary to develop and manufacture lyophilized products successfully.

To order your copy of Principles and Practice of Lyophilization Process and Product Development, simply click on the link below. Don’t miss out on this invaluable resource that will revolutionize your understanding of the lyophilization process.

Order Now

Product Details

  • Publisher ‏ : ‎ Springer; 1st ed. 2023 edition (April 25, 2023)
  • Language ‏ : ‎ English
  • Hardcover ‏ : ‎ 636 pages
  • ISBN-10 ‏ : ‎ 3031126335
  • ISBN-13 ‏ : ‎ 978-3031126338

Related Products