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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
Language: en
Pages: 597
Authors: John Geigert
Categories: Science
Type: BOOK - Published: 2023-06-15 - Publisher: Springer Nature

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Each year for the past three years, there have been about 50 new molecular medicines approved by the United States Food & Drug Administration (FDA), of which ap
The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
Language: en
Pages: 362
Authors: John Geigert
Categories: Medical
Type: BOOK - Published: 2014-07-08 - Publisher: Springer Science & Business Media

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This book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importa
Glaxo
Language: en
Pages: 438
Authors: R. P. T. Davenport-Hines
Categories: Business & Economics
Type: BOOK - Published: 1992-11-26 - Publisher: Cambridge University Press

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This 1992 study of Glaxo, from its beginnings to 1962, examines the global operations of this pharmaceutical company.
Peptide Therapeutics
Language: en
Pages: 572
Authors: Ved Srivastava
Categories: Science
Type: BOOK - Published: 2019-08-28 - Publisher: Royal Society of Chemistry

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Peptide therapy has become a key strategy in innovative drug development, however, one of the potential barriers for the development of novel peptide drugs in t
Development of Biopharmaceutical Drug-Device Products
Language: en
Pages: 888
Authors: Feroz Jameel
Categories: Medical
Type: BOOK - Published: 2020-03-13 - Publisher: Springer Nature

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The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), B