Sarfaraz K. Niazi, Sunitha Lokesh

Biopharmaceutical Manufacturing, Volume 1 (eBook, ePUB)

Regulatory processes

• Format: ePub

Produktbeschreibung

Biopharmaceuticals are drug products that are manufactured in, extracted from, or synthesised from biological sources. The commercial biomanufacture of products intended for human use is a complex art and science that differs from the manufacture of chemical pharmaceuticals. The field has transformed over the past two decades as a variety of new products based on genetic modifications and coding have emerged, which has required the development of new technologies.

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. Case studies and step-by-step procedures for the complete manufacturing of specific products are provided at the end of each chapter.

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.

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Produktdetails

• Verlag: Institute of Physics Publishing
• Seitenzahl: 350
• Erscheinungstermin: 31. Dezember 2021
• Englisch
• ISBN-13: 9780750331753
• Artikelnr.: 63263553

Autorenporträt

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.

Sunitha Lokesh is the director of biomanufacturing operations at Pharmaceutical Scientist Inc., where she leads the identification and technology development of biopharmaceutical products. She has over 10 years of experience in developing biopharmaceuticals, from the cell line to process validation.