An ambitious 10-year collaborative program is described to invent, design, demonstrate, and support commercialization of integrated biopharmaceutical manufacturing technology intended to transform the industry. Our goal is to enable improved control, robustness, and security of supply, dramatically reduced capital and operating cost, flexibility to supply an extremely diverse and changing portfolio of products in the face of uncertainty and changing demand, and faster product development and supply chain velocity, with sustainable raw materials, components, and energy use. The program is organized into workstreams focused on end-to-end control strategy, equipment flexibility, next generation technology, sustainability, and a physical test bed to evaluate and demonstrate the technologies that are developed. The elements of the program are synergistic. For example, process intensification results in cost reduction as well as increased sustainability. Improved robustness leads to less inventory, which improves costs and supply chain velocity. Flexibility allows more products to be consolidated into fewer factories, reduces the need for new facilities, simplifies the acquisition of additional capacity if needed, and reduces changeover time, which improves cost and velocity. The program incorporates both drug substance and drug product manufacturing, but this paper will focus on the drug substance elements of the program.

中文翻译：

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端到端合作以改变生物制药的开发和制造

描述了一个雄心勃勃的 10 年合作计划，旨在发明、设计、演示和支持旨在改变行业的综合生物制药制造技术的商业化。我们的目标是提高供应的控制力、稳健性和安全性，显着降低资本和运营成本，在面临不确定性和不断变化的需求时灵活地提供极其多样化和不断变化的产品组合，以及更快的产品开发和供应链速度，具有可持续的原材料、组件和能源使用。该计划分为工作流，重点关注端到端控制策略、设备灵活性、下一代技术、可持续性和物理测试台，以评估和展示所开发的技术。该计划的要素是协同的。例如，工艺强化可以降低成本并提高可持续性。提高稳健性可减少库存，从而提高成本和供应链速度。灵活性允许将更多产品整合到更少的工厂，减少对新设施的需求，在需要时简化额外产能的获取，并减少转换时间，从而提高成本和速度。该计划包含原料药和制剂生产，但本文将重点关注该计划的原料药要素。灵活性允许将更多产品整合到更少的工厂，减少对新设施的需求，在需要时简化额外产能的获取，并减少转换时间，从而提高成本和速度。该计划包含原料药和制剂生产，但本文将重点关注该计划的原料药要素。灵活性允许将更多产品整合到更少的工厂，减少对新设施的需求，在需要时简化额外产能的获取，并减少转换时间，从而提高成本和速度。该计划包含原料药和制剂生产，但本文将重点关注该计划的原料药要素。