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  • Format: ePub

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.
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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 unit processes involved in producing a GMP (Good Manufacturing Practice) biopharmaceutical product, laid out in the order of operation, with complete details on equipment, compliance and yield improvement suggestions. The unit processes described include several emerging trends and advice on reducing the costs of the product and efficient scale up techniques.

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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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.