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Authored by renowned experts Ralf Huss, Christine Guenther, and Andrea Hauser, this textbook presents a thorough overview of the development of cell-based biopharmaceuticals, covering the entire spectrum from preclinical concept to clinical trial initiation.
The journey begins with an in-depth exploration of the underlying biology of stem cells and cell-based products, followed by a detailed analysis of the complex regulatory landscapes in Europe, North America, and other regions.
The authors outline a step-by-step approach to manufacturing clinical-grade therapeutics, ensuring the development of robust and marketable products that meet stringent quality measures.
Furthermore, the book provides an outlook on next-generation products and innovative strategies, offering valuable insights for professionals and researchers in the field of biopharmaceuticals.
This reference book is an essential resource for:
With its comprehensive coverage and expert insights, this book is a valuable addition to any library or institution involved in biopharmaceutical research and development.
Product Details:
ISBN-13: 9789814616782
Publisher: World Scientific Publishing Company, Incorporated
Publication Date: September 25, 2015
Pages: 200
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