Development of Biopharmaceutical Drug-Device Products

The biotechnology/biopharmaceutical sector has grown, leading to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins. Regulatory agencies have raised the bar for the development and manufacture of antibody-based products, expecting to see the use of Quality by Design (QbD) elements. Drug delivery systems have become an increasingly important part of the therapy, and most biopharmaceuticals for self-administration are being marketed as combination products.

Format: Paperback / softback
Length: 893 pages
Publication date: 26 August 2021
Publisher: Springer Nature Switzerland AG

The biotechnology/biopharmaceutical sector has experienced remarkable growth, leading to the development of innovative engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins. These therapeutic agents are now being utilized for the treatment of immunology, oncology, and various other disease conditions. Regulatory bodies have heightened their expectations for the development and manufacturing of antibody-based products, emphasizing the importance of incorporating Quality by Design (QbD) elements that demonstrate a deep understanding of the product and process based on robust scientific principles.

Drug delivery systems have become an integral component of therapeutic interventions, with the majority of biopharmaceuticals being marketed as combination products for self-administration. A comprehensive survey of the market reveals a significant demand for a new book that offers a comprehensive and up-to-date overview of the recent scientific and engineering advancements in the field of biopharmaceutical product development.

To address this need, we are pleased to introduce Development of Biopharmaceutical Drug Device Products, a valuable reference text for scientists and engineers working in the biopharmaceutical industry, academia, or regulatory agencies. This comprehensive book is authored by experts in the field and provides a comprehensive review of first principles, recent technological advancements, and case studies related to the development and manufacture of antibody-based products.

The book begins by delving into the importance of early preformulation studies during drug discovery, emphasizing their role in influencing molecular selection for development. It then explores various formulation strategies for new modalities, including nanoparticles, liposomes, and gene therapy vectors. The analytical techniques used to characterize these formulations are also discussed in detail.

Furthermore, the book addresses critical considerations in the development and manufacture of antibody-based products, such as quality control, stability testing, and regulatory strategies. It provides insights into the challenges faced by biopharmaceutical companies and offers practical solutions to ensure the safe and effective translation of innovative therapies from the laboratory to the patient.

Development of Biopharmaceutical Drug Device Products is an essential resource for scientists, engineers, and professionals involved in the biopharmaceutical industry. Its insightful chapters, written by esteemed experts, offer a comprehensive and up-to-date perspective on the field, enabling readers to stay at the forefront of this rapidly evolving sector.

In conclusion, the biotechnology/biopharmaceutical sector has witnessed significant growth, driven by the development of innovative engineered antibodies and drug delivery systems. Regulatory agencies have raised the bar for product development, emphasizing the importance of robust scientific principles and quality by design. To meet these demands, we are proud to present Development of Biopharmaceutical Drug Device Products, a valuable reference text that provides comprehensive coverage of the latest scientific and engineering advancements in the field. This book is a must-have for scientists, engineers, and professionals seeking to stay informed and advance their knowledge in biopharmaceutical product development.

Weight: 1371g
Dimension: 235 x 155 (mm)
ISBN-13: 9783030314170
Edition number: 1st ed. 2020