Formulation and Process Development Strategies for
Manufacturing Biopharmaceuticals, 1st Edition" by Feroz Jameel and Susan Hershenson
"Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals, 1st Edition" by Feroz Jameel and Susan Hershenson
"Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals" is a necessary and detailed guide to comprehending the complex process of formulating and producing biopharmaceuticals. Edited by industry professionals Feroz Jameel and Susan Hershenson, this first edition is an invaluable resource for biopharmaceutical and biotechnology professionals.
The book centers on the formulation and process development areas that are critical to developing safe, effective, and scalable biopharmaceuticals. These are advanced drugs that originate from biological material, and their production process is fraught with numerous variables that require meticulous attention. This book equips readers with a comprehensive outline of how to overcome these challenges, from research to large-scale manufacture.
Overview of Biopharmaceuticals Manufacturing: The monograph begins with a general overview of the manufacturing process of biopharmaceuticals, starting with an insight into biologic drugs like monoclonal antibodies, vaccines, and cell and gene therapies. It describes the basics of formulation and process development against the background of these biologics.
Formulation Development: The design and development of drug formulations to provide stability, efficacy, and safety of the final biopharmaceutical product is one of the most important sections of the book. Stability studies, excipients selection, and optimization of delivery systems are some of the topics discussed in detail.
Process Development: The book also explores in-depth the process development approaches that are important for converting a laboratory-scale product to one that can be manufactured at a commercial level. Process development approaches covered include fermentation optimization, protein expression systems, purification techniques, and scale-up processes.
Regulatory Implications: Another dominant theme touched upon in the book is the regulatory issues. The authors mention the regulatory standards that control the approval of biopharmaceutical products, including the guidelines laid down by the FDA, EMA, and other international health organizations.
Quality Control and Assurance: Ensuring the quality of a biopharmaceutical product is critical, and this book places significant importance on quality control (QC) and quality assurance (QA) practices. From raw material testing to product release, the book discusses how stringent QC/QA techniques are utilized at every step to provide safety and efficacy.
Case Studies and Real-World Applications: The book contains real-world case studies from industry experts that offer real-life examples of challenges encountered in biopharmaceutical development and how they were resolved. These case studies enrich the learning process and offer readers useful insights into industry practices.
This book targets professionals working in the biopharmaceutical industry, such as formulation scientists, process development professionals, regulatory affairs experts, and researchers. The book is also a valuable textbook for graduate students pursuing biotechnology, pharmaceutical science, and biopharmaceutical manufacturing.
Why This Book is Important:
Manufacturing biopharmaceuticals is a fast-paced field, with more biologic drugs coming onto the market. The intricacies of making these drugs, which tend to be high-tech and need strict quality control, can be overwhelming. This book offers expert advice on overcoming these issues, presenting a blend of scientific fundamentals, engineering principles, and regulatory considerations. It assists readers in comprehending the state-of-the-art approaches required to move biopharmaceuticals from the laboratory to bulk production.
"Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals" is a valuable guide for everyone who works in the biopharmaceutical industry. Through the presentation of a comprehensive, practical, and scientific method of approaching the formulation and manufacturing process of biopharmaceutical products, this book is an essential resource for professionals trying to keep up with the needs of the expanding global biopharmaceutical industry. Whether you’re just beginning your career in biopharmaceuticals or are an experienced industry veteran, the strategies outlined in this book will enhance your ability to develop, scale, and bring biopharmaceutical products to market effectively.
For Buy Book Go the Link:
Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals: 9780470118122: Medicine & Health Science Books @ Amazon
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