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By Laura I. Salazar-Fontana, Ph.D., and Daniela Drago, Ph.D., RAC, NDA Partners | Variability is inherent to biologics manufacturing. The trick is to catch it quickly and prevent product quality drift. That’s where the new ICH Q14 comes in. |
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By Mo Heidaran, Cellx Inc. | Lipid nanoparticles have generated a ton of buzz, but they pose risks that, perhaps, industry and regulators have not taken seriously enough so far. |
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