PRINCIPLES OF BIOPHARMACEUTICALS: THE SCIENCE AND ENGINEERING OF DRUG DEVELOPMENT

The development of biopharmaceuticals represents a convergence of
biology, chemistry, and engineering, revolutionizing healthcare and
offering new ways to treat diseases at their molecular roots. This
book, Principles of Biopharmaceuticals: The Science and
Engineering of Drug Development, provides a comprehensive
exploration of the science behind biopharmaceutical products and
the technical and engineering practices involved in their
development, production, and regulation.
As biopharmaceuticals continue to grow in importance within the
pharmaceutical landscape, the need for well-rounded expertise in
this field has become essential. This book is designed to serve as a
valuable resource for professionals, researchers, and students
involved in biopharmaceutical sciences, bioengineering, and related
fields. Covering foundational concepts as well as advanced topics, it
offers both a theoretical understanding and practical insights into the
complexities of biopharmaceutical processes.
The book is divided into several chapters, each focused on a different
aspect of biopharmaceutical science and engineering. Beginning
with an overview of biopharmaceutical products and production
processes, it moves on to detailed discussions on cell structure and
harvest operations, including various methods of cell lysis and
separation techniques. Chromatography and other purification
methods are presented with an emphasis on the principles and
applications essential for achieving product quality and consistency.
Further, the book addresses formulation processes, ultrafiltration,
and tangential flow filtration methods, which are critical in finalizing
the drug product. The final chapter provides an in-depth exploration
of the drug development process itself, including the emerging roles
of biotechnology and molecular engineering in creating new
therapeutic platforms.
This book aims to bridge the knowledge gap for both newcomers to
the field and seasoned professionals. Researchers and practitioners
will find value in the technical explanations and step-by-step
descriptions of biopharmaceutical manufacturing techniques, while
students and educators can use the book as an instructional guide for
courses in biopharmaceutical engineering and science.
A work of this scope is made possible through the contributions of
many experts in the fields of biopharmaceutical development,
process engineering, and regulatory science. Their insights and
pioneering research form the backbone of the information presented
here, and we extend our deepest appreciation to those who have
shared their knowledge and expertise.
We hope this book will serve as both a reference and an inspiration,
equipping readers with the knowledge to contribute meaningfully to
the evolving field of biopharmaceuticals and advancing the goal of
improving human health worldwide.