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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
Combination Products
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Authors: Smita Gopalaswamy
Categories: Business & Economics
Type: BOOK - Published: 2008-04-22 - Publisher: CRC Press

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The field of combination product development (products born of the integration of medical devices, biologics, and drugs) is so new that, while literature abound
Biocontamination Control for Pharmaceuticals and Healthcare
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Authors: Tim Sandle
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Biocontamination Control for Pharmaceuticals and Healthcare outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition
Development of Biopharmaceutical Drug-Device Products
Language: en
Pages: 888
Authors: Feroz Jameel
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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