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Biopharmaceutical Manufacturing, Volume 1: Regulatory processes (IOP ebooks, Band 1) - Hardcover

Niazi, Sarfaraz K.; Lokesh, Sunitha

 
9780750331739: Biopharmaceutical Manufacturing, Volume 1: Regulatory processes (IOP ebooks, Band 1)
Hardcover
ISBN 10: 0750331739 ISBN 13: 9780750331739
Verlag: IOP Publishing, 2022

Inhaltsangabe

This two-volume set provides a comprehensive guide to the essential aspects of commercial biopharmaceutical manufacturing. Covering the planning, layout and operation of successful commercial manufacturing, the aim of the books is to enable innovations, new drug development, and make affordable biological drugs available to patients worldwide. 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.

Key Features:

  • Covers the essential aspects of commercial biopharmaceutical manufacturing for industry practitioners, including the planning, layout and operation
  • Provides sufficient information for industry practitioners to establish and operate GMP (Good Manufacturing Practice) compliant manufacturing operations
  • Includes case studies and step-by-step procedures for manufacturing specific biopharmaceutical products
  • Focused exclusively on products intended for human use
  • Includes coverage of regulatory requirements, intellectual property challenges, training of manufacturing teams and issues around cost optimisation

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Über die Autorin bzw. den Autor

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.

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Verlag
IOP Publishing
Erscheinungsdatum
2022
Sprache
Englisch
ISBN 10 
0750331739
ISBN 13 
9780750331739
Einband
Gebundene Ausgabe
Anzahl der Seiten
448
Kontakt zum Hersteller
Nicht verfügbar
Verantwortliche Person
GPSR Kontakt
gpsr@libri.de

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