Biopharmaceutical Manufacturing, Volume 1 - Regulatory processes

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.

About the author

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.

Product details

• Authors: Sunitha Lokesh, Sunitha (Pharmaceutical Scientist) Lokesh, Professor Sarfaraz K. (Professor Niazi, Sarfaraz Niazi, Sarfaraz K Niazi, Sarfaraz K. Niazi
• Publisher: Institute of Physics Publishing
• Languages: English
• Product format: Hardback
• Released: 31.12.2021
• EAN: 9780750331739
• ISBN: 978-0-7503-3173-9
• No. of pages: 448
• Dimensions: 178 mm x 254 mm x 25 mm
• Weight: 991 g
• Illustrations: With figures in colour and black and white
• Series: IOP ebooks
• Subject: Natural sciences, medicine, IT, technology > Technology > Mechanical engineering, production engineering