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Determining developability and accelerating feasibility studies can greatly improve a drug's chances of moving through development. By using an optimized transient transfection platform, drug developers can accelerate their characterization and early development activities, facilitating continuity for a drug's scale-up.
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Intensified fed-batch (IFB) culture offers a significant improvement over traditional fed-batch (TFB) methods for biopharmaceutical production. By incorporating perfusion processes, IFB enables higher cell densities, shorter growth phases, and extended production periods, ultimately leading to increased productivity and improved product quality.
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Quality by Design (QbD) transforms biopharmaceutical development by prioritizing risk mitigation and quality throughout every part of a process. Originally pursued for medical devices, this proactive approach ensures consistent high-quality drugs and simplifies regulatory approval by managing variability and building robust processes, empowering developers to get drugs "right the first time."
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