Znerak
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Biopharmaceutical Manufacturing, Volume 1_Regulatory Processes
English | 2022 | ISBN: 0750331739 | 448 pages | True epub | 7 MB
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.
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