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| Successful analytical assay development relies on a profound understanding of method development theories and the ability to prioritize the right parameters. The resulting, well-structured product life cycle drives production efficiency and higher-quality therapeutics. Each failure in method development or execution delays the delivery of crucial products to patients. Learn more. |
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By Deborah Livornese, Hyman, Phelps & McNamara | CDER recently moved from sharing reviews from individual disciplines in public documents to an Integrated Review, which includes conclusions but much less detail. |
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FOCUS ON ANALYTICS & QUALITY |
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By Yiming Peng and Margaux Penwarden, Roche | Roche has pushed through so-called "pilot purgatory" and rolled out artificial intelligence solutions in the real world. Two of its data leaders describe three case studies. |
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| Digital Transformation - The Power Of Your Data | Case Study | Aizon | Discover how you can circumvent numerous recirculations during the ultrafiltration process step, boost downstream bioprocess yield, and identify and resolve process inefficiencies. |
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| How Two Life Science Leaders Unlocked Pharma 4.0 Success | Article | By Torey Penrod-Cambra, HighByte | Gain valuable insights from digitalization leaders on how some life sciences manufacturers are successfully scaling their Pharma 4.0 initiatives beyond the pilot stage and paving the way forward. |
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ANALYTICS & QUALITY SOLUTIONS |
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