Christine Heyer; Georg Häfele; Gustav Neuthinger; Annelie Schmidt; Elena Waggershauser; Harry Walter Cornelsen Verlag GmbH (2010) Saatavuus: Tilaustuote Pehmeäkantinen kirja
Eva Borst; Ulrich Brand; Peter Dehnbostel; Andreas Dietschi; Lilian Frankhauser; Christine Goll Rotpunktverlag (2014) Saatavuus: Hankintapalvelu Pehmeäkantinen kirja
Hannes Böhringer; Michael Cowan; Tom Gunning; Susanne Hauser; Christine Hoffmann; Hans-Werner Ingensiep; Julia Jahnke; vo Verlag für moderne Kunst (2013) Saatavuus: Tulossa! Kovakantinen kirja
This textbook is a comprehensive overview of the development of cell-based biopharmaceuticals. Beginning with the underlying biology of stem cell and cell-based products, it traces the long and complex journey from preclinical concept to initiation of a pivotal clinical trial and the potential business model behind it.The book also takes into consideration the different regulatory landscapes and their continuous evolution in Europe, North America and other parts of the world. The authors describe a path to manufacture a clinical grade therapeutic that passes all necessary quality measures as a robust and marketable product including an outlook on next generation products and innovative strategies.This reference book is a must-have guide for any professional already active in biopharmaceuticals and anyone interested in getting involved in a scientific, medical or business capacity.