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Principles and Practices of Lyophilization in Product Development and Manufacturing

AAPS Advances in the Pharmaceutical Sciences Series -Band 59

The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T cell engager ( BITES), Dual Vari…

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John Geigert

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

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.…

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Specification of Drug Substances and Products

Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Third Edition contains chapters discussing the unique requirements for the universal critical quality attri…

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