National Institute for Innovation in Manufacturing Biopharmaceuticals, Newark, Delaware, USA.
Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Biotechnol Bioeng. 2021 Sep;118(9):3302-3312. doi: 10.1002/bit.27688. Epub 2021 Feb 2.
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.
一个雄心勃勃的 10 年合作计划旨在发明、设计、展示和支持集成生物制药制造技术的商业化，以改变行业。我们的目标是实现更好的控制、稳健性和供应安全性，大幅降低资本和运营成本，在面对不确定性和不断变化的需求时提供供应极其多样化和不断变化的产品组合的灵活性，以及更快的产品开发和供应链速度，同时可持续地使用原材料、组件和能源。该计划分为多个工作组，重点关注端到端控制策略、设备灵活性、下一代技术、可持续性以及用于评估和展示所开发技术的物理测试平台。该计划的各个要素相互协同。例如，工艺强化不仅降低了成本，还提高了可持续性。提高稳健性可以减少库存，从而降低成本并提高供应链速度。灵活性允许将更多的产品合并到更少的工厂中，减少对新设施的需求，如果需要，简化额外产能的获取，并减少转换时间，从而降低成本并提高速度。该计划涵盖了药物物质和药物产品的制造，但本文将重点介绍该计划中药物物质的部分。
