This volume covers the regulatory processes involved in producing a GMP (Good Manufacturing Practice) biopharmaceutical product for commercial distribution, including areas of current GMP, registration, and legal and ethical considerations. Emerging trends in the technology and regulatory compliance are also discussed, with advice on establishing efficient manufacturing facilities. Intended for practitioners in the commercial biopharmaceutical manufacturing industry, the text is an ideal resource for practitioners looking to develop their ability to manufacture biopharmaceutical products at a large scale.
Reihe
Sprache
Verlagsort
Zielgruppe
Produkt-Hinweis
Fadenheftung
Gewebe-Einband
Illustrationen
With figures in colour and black and white
Maße
Höhe: 254 mm
Breite: 178 mm
Dicke: 25 mm
Gewicht
ISBN-13
978-0-7503-3173-9 (9780750331739)
DOI
10.1088/978-0-7503-3175-3
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Klassifikation
Sarfaraz K. Niazi is an adjunct professor at the University of Illinois and University of Houston. Prof. Niazi has established numerous consulting businesses and start-up companies within the biopharmaceutical industry, including Pharmaceutical Scientist, Inc and Karyo Biologics, LLC. He has published over 100 research articles and is the author of numerous textbooks on biotechnology and pharmaceutical manufacturing.
Autor*in
ProfessorUniversity of Illinois and University of Houston
Pharmaceutical Scientist
