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By BioPhorum | While commissioning, qualification, and validation (CQV) remains foundational, the way it is planned and executed must evolve to keep pace with modern manufacturing realities. | |
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By Todd Kapp, Kivi Bio | The missing link between data generation and unleashing it to power automation often lies in well-governed cloud infrastructure. | |
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By Ki Tae Bong, Samsung Bioepis | Biosimilar development often reveals quality drifts in certain lots of the reference biologic. In most cases, quality changes are noncritical, but some drifts can impact CQAs. | |
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