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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
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Peptide Therapeutics
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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
Regulatory Aspects of Gene Therapy and Cell Therapy Products
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Bioprocessing for Biomolecules Production
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Presents the many recent innovations and advancements in the field of biotechnological processes This book tackles the challenges and potential of biotechnologi