Biological Drug Products (PDF)

Tested and proven solutions to the challenges of biological
drug product development

Biological drug products play a central role in combating human
diseases; however, developing new successful biological drugs
presents many challenges, including labor intensive production
processes, tighter regulatory controls, and increased market
competition. This book reviews the current state of the science,
offering readers a single resource that sets forth the fundamentals
as well as tested and proven development strategies for biological
drugs. Moreover, the book prepares readers for the challenges that
typically arise during drug development, offering straightforward
solutions to improve their ability to pass through all the
regulatory hurdles and deliver new drug products to the market.

Biological Drug Products begins with general
considerations for the development of any biological drug product
and then explores the strategies and challenges involved in the
development of specific types of biologics. Divided into five
parts, the book examines:

* Part 1: General Aspects

* Part 2: Proteins and Peptides

* Part 3: Vaccines

* Part 4: Novel Biologics

* Part 5: Product Administration/Delivery

Each chapter has been prepared by one or more leading experts in
biological drug development. Contributions are based on a
comprehensive review and analysis of the current literature as well
as the authors' first-hand experience developing and testing new
drugs. References at the end of each chapter serve as a gateway to
original research papers and reviews in the field.

By incorporating lessons learned and future directions for
research, Biological Drug Products enables pharmaceutical
scientists and students to improve their success rate in developing
new biologics to treat a broad range of human diseases.