Pharmaceutical Biotechnology: Fundamentals and Applications

This textbook provides a comprehensive overview of pharmaceutical biotechnology, including basic science, production, quality, dosage forms, administration, economic and regulatory aspects, and clinical applications. It is updated for the sixth edition and includes coverage of new approaches such as oligonucleotides, siRNA, mRNA, gene therapy, cell therapies, monoclonal antibodies, and vaccines. It is widely distributed as a key educational resource for the field.

Format: Hardback
Length: 682 pages
Publication date: 05 January 2024
Publisher: Springer International Publishing AG

This comprehensive introductory text delves into the multifaceted realm of biotechnology-derived pharmaceuticals, encompassing both the fundamental scientific principles and the practical aspects of their production, quality assurance, dosage forms, administration, economic considerations, and regulatory frameworks. Serving as an invaluable resource for undergraduate and graduate pharmacists, as well as pharmaceutical science students, this text provides a one-stop destination for acquiring comprehensive knowledge in the field. Moreover, it holds significance for pharmaceutical scientists in industry and academia, particularly those who may lack formal training in pharmaceutical biotechnology and require an entry point into this dynamic domain.

The rapid advancements and exponential growth in this field have necessitated the need for a revised edition, ensuring that readers remain well-informed and acquainted with the latest knowledge and cutting-edge technologies. The Sixth Edition of this textbook undergoes a thorough update, encompassing extensive coverage of emerging approaches such as oligonucleotides, siRNA, mRNA, gene therapy, cell therapies, monoclonal antibodies, and vaccines. With over 3 million chapter downloads, the fifth edition has achieved widespread distribution as a pivotal educational resource in the realm of pharmaceutical biotechnology.

The text is organized into distinct chapters, each dedicated to exploring specific aspects of biotechnology-derived pharmaceuticals. The first chapter provides an overview of the basic principles of biotechnology, including genetic engineering, molecular biology, and recombinant DNA technology. It lays the foundation for understanding the subsequent chapters, which delve into the production, characterization, and purification of pharmaceutical proteins.

The second chapter focuses on the manufacturing processes employed in biotechnology-derived pharmaceuticals, including fermentation, cell culture, and chromatography. It discusses the key steps involved in drug development, from the selection of appropriate expression systems to the purification and formulation of the final product.

The third chapter explores the quality control and assurance of biotechnology-derived pharmaceuticals, emphasizing the importance of stringent testing and quality management throughout the manufacturing process. It discusses various analytical techniques, such as HPLC, UV-Vis, and mass spectrometry, used for the identification, quantification, and characterization of pharmaceutical compounds.

The fourth chapter delves into the dosage forms and administration of biotechnology-derived pharmaceuticals, including oral, injectable, and topical preparations. It discusses the factors influencing drug absorption, distribution, metabolism, and excretion, as well as the strategies employed to enhance the bioavailability and stability of these products.

The fifth chapter explores the economic and regulatory aspects of biotechnology-derived pharmaceuticals, including the costs associated with drug development, pricing strategies, and the approval process by regulatory agencies such as the FDA and EMA. It also discusses the ethical considerations and social implications of biotechnology-derived pharmaceuticals.

The sixth chapter focuses on the clinical applications of biotechnology-derived pharmaceuticals, including their use in the treatment of various diseases, such as cancer, diabetes, and rheumatoid arthritis. It discusses the mechanisms of action of these products, their safety and efficacy profiles, and the challenges associated with their clinical development and commercialization.

In conclusion, this comprehensive introductory text serves as a valuable resource for pharmacists, pharmaceutical science students, pharmaceutical scientists, and healthcare professionals seeking to gain a deeper understanding of biotechnology-derived pharmaceuticals. It provides a comprehensive coverage of the fundamental science, production, quality, dosage forms, administration, economic and regulatory aspects, and clinical applications of these products. With its up-to-date information and cutting-edge insights, the Sixth Edition of this textbook is poised to become a staple in the field, empowering readers to stay at the forefront of this rapidly evolving industry.

Weight: 1953g
Dimension: 279 x 210 (mm)
ISBN-13: 9783031300226
Edition number: 6th ed. 2024