Formulation and process development strategies for manufacturing biopharmaceuticals

Pharmaceutical scientists face a lack of information about the biopharmaceutical product development and commercialization process. Where available, such information is often inadequate and growing outdated because of the rapid development and constantly changing compliance landscape for regulations and marketing. This book fills this information gap, serving as a comprehensive overviewand guide to biopharmaceutical development and manufacturing. The book coversfundamentals and essential pathways for each phase; as well as the purpose, function, and relation to other stages in the product development process. Contributors from both industry and academia bring a blend of perspectives and expertise to pharmaceutical readers. In addition, the book provides case histories related to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions. Examples of successful and failed products and the reasons for these will be discussed and analyzed.

• ISBN: 978-0-470-11812-2
• Editorial: John Wiley & Sons
• Encuadernacion: Cartoné
• Páginas: 976
• Fecha Publicación: 09/07/2010
• Nº Volúmenes: 1
• Idioma: Inglés