

An edition of PAT applied in biopharmaceutical process development and manufacturing (2011)
an enabling tool for quality-by-design
By Cenk Undey
Publish Date
2012
Publisher
CRC Press
Language
eng
Pages
324
Description:
"This book summarizes the state of the art in process analytical technologies applied to various aspects of biopharmaceutical process development and manufacturing. The text summarizes regulatory perspectives, FDA/EMEA guidelines, and new expectations. In addition, it explores new technology, especially in the area of real-time monitoring for end-point control as well as new sensor and analytical technologies. It details established and emerging measurement technologies, including future needs and challenges that require further research. The authors also present successful industrial-scale deployment case studies and strategies from the biopharmaceutical industry and discuss future trends"--
subjects: Biopharmaceutics, SCIENCE / Biotechnology, SCIENCE / Chemistry / Analytic, Drug development, Pharmaceutical biotechnology, MEDICAL / Pharmacology, Drugs, Pharmaceutical Preparations, Methods, Drug Compounding, Pharmaceutical Technology, Standards, Biotechnologie pharmaceutique, Biopharmacie, Médicaments, Développement, MEDICAL, Drug Guides, Nursing, Pharmacology, Pharmacy, Pharmazeutische Technologie, Pharmazeutische Biologie, Arzneimittel, Forschung und Entwicklung