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

Niazi, Sarfaraz K.; Lokesh, Sunitha

 
9780750331739: Biopharmaceutical Manufacturing: Regulatory Processes (1) (IOP ebooks, Band 1)

Inhaltsangabe

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.

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Über die Autorin bzw. den Autor

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.

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Weitere beliebte Ausgaben desselben Titels

9780750331760: Biopharmaceutical Manufacturing, Volume 1: Regulatory processes

Vorgestellte Ausgabe

ISBN 10:  0750331763 ISBN 13:  9780750331760
Verlag: Institute of Physics Publishing, 2021
Softcover