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Evolving CMC Analytical Techniques for Biopharmaceuticals

1.0 Abstract During the (early) preclinical drug development process as well as manufacturing of biopharmaceutical (protein) products, analysis and characterization are crucial in gaining a...

When Data Integrity Takes Center Stage

1.0 Abstract Data integrity has become an important issue. To comply with regulations, companies need to optimize data integrity and the underlying strategies involved in...