Télécharger le livre :  The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
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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 approximately 25% were new biopharmaceuticals. Over 200 recombinant proteins, monoclonal antibodies, antibody...

Editeur : Springer
Parution : 2023-06-15

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137,14
Télécharger le livre :  The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
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Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry.  And not just the recombinant DNA-derived proteins and monoclonal...

Editeur : Springer
Parution : 2019-05-08

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158,24
Télécharger le livre :  The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
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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 importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into...

Editeur : Springer
Parution : 2014-07-08

ePub

179,34