Overview
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.
Full Product Details
Author: Wei Wang ,
Manmohan Singh
Publisher: John Wiley & Sons Inc
Imprint: John Wiley & Sons Inc
Dimensions:
Width: 15.50cm
, Height: 4.30cm
, Length: 23.90cm
Weight: 1.157kg
ISBN: 9781118148891
ISBN 10: 1118148894
Pages: 744
Publication Date: 29 November 2013
Audience:
Professional and scholarly
,
Professional & Vocational
Format: Hardback
Publisher's Status: Active
Availability: Out of stock
The supplier is temporarily out of stock of this item. It will be ordered for you on backorder and shipped when it becomes available.
Reviews
Thus, it will be a valuable resource for both novice and expert alike. (ChemMedChem, 1 October 2014)
Thus, it will be a valuable resource for both novice and expert alike. (ChemMedChem, 1 October 2014)
Author Information
WEI WANG, PhD, is a Research Fellow for Pfizer BioTherapeutics Pharmaceutical Sciences. In addition, Dr. Wang is Adjunct Professor in the School of Pharmacy and Health Sciences at the University of the Pacific. MANMOHAN SINGH, PhD, is Head of Technical Development at Novartis Vaccines and Diagnostics. Dr. Singh has authored over 120 peer-reviewed manuscripts, reviews, and book chapters in the area of vaccine formulations and adjuvant research. He is also an Adjunct Professor at the Eshelman School of Pharmacy at University of North Carolina, Chapel Hill.
