Advances in Pharmaceutical Cell Therapy: Principles of Cell-Based Biopharmaceuticals

ISBN-13: 9789814616782 / Angielski / Twarda / 2015 / 564 str.

Ralf Huss; Christine Guenther; Andrea Hauser

Opis

This textbook is a comprehensive overview of the emerging field of cell-based biopharmaceuticals starting from the underlying biology of stem cell and cell-based products all the way to the initiation of a pivotal clinical trial and the potential business model behind it.It also takes into consideration the different regulatory landscapes in Europe, North America and other parts of the world and describes a way to manufacture a pharmaceutical-grade therapeutic that passes all necessary quality measures as a robust and marketable product. This is an important guide for any professional in the field of cell-based biopharmaceuticals, needing insights from scientific, medical and business perspectives in one convenient volume.