Biopharmaceuticals purification by continuous membrane-assisted crystallization achieving lower cost and intensified processes (BIOPURE)

随着全球对生物药物的需求不断增长，以解决新的治疗领域，BIOPURE项目将通过实施全新的破坏性技术来实现单克隆抗体（mAb）纯化的一步变化，以直接从无细胞培养液中回收固态mAb产品。BIOPURE承诺以更小的占地面积降低制造和购买设备的成本。与基于标准色谱的平台相比，它简化了物流链，并通过避免大量使用化学品来增强环境可持续性。它为新的可能性和生物医学打开了大门，迄今为止在经济上或技术上都极具挑战性。最终的结果是，公民将有机会获得更负担得起的和多样化的新一代生物医学选择。所提出的基于膜的技术已经在实验室规模（TRL4）上被证明是用于mAb纯化的蛋白A色谱法的更便宜且易于扩展的替代方案。下一步是展示该技术的通用效率，并通过设计一个全自动化的原型将其扩展到TRL6，该原型将连续运行，并能够符合生物制药生产的质量和法规。除了技术开发，新的BIOPURE技术将与真实的市场参与者进行验证，从而验证计划的商业模式，知识产权管理计划以及上市战略中包含的相关财务规划。通过实现BIOPURE的主要目标，预计采用膜辅助方法进行mAb产品纯化将在通过连续生产提高生产效率和通过工艺强化降低成本方面取得突破性进展。

With the growing global demand for biological medicines to address new therapeutic areas, the BIOPURE project will deliver a step change in monoclonal antibodies (mAbs) purification through the implementation of radically new and disruptive technology to recover mAbs-products in the solid-state directly from cell-free culture fluids. BIOPURE promises to lower manufacturing and purchase of equipment costs with a smaller footprint. It simplifies logistic chains and enhances environmental sustainability by avoiding extensive use of chemicals, compared to the standard chromatography-based platforms. It opens the doors to new possibilities and biomedicines so far too challenging economically or technologically. As end result, the citizens will have access to a more affordable and diverse selection of new generation biomedicines. The proposed membrane-based technology has already been proved at the laboratory scale (TRL4) as a cheaper and easily scalable alternative to protein A chromatography for mAb purification. The next step is to demonstrate the generalized efficiency of the technology and scale it up to TRL6 through the design of a fully automatized prototype that will be operated continuously and capable of compliance with quality and regulations for biopharmaceutical productions. In addition to technological development, the new BIOPURE technology will be validated with real market players, leading to verifying the planned business model, the IPR management plan, and the associated financial planning included in the go-to-market strategy. By achieving the main objectives of BIOPURE, it is expected that the adoption of membrane-assisted method for mAb-products purification will provide a breakthrough advancement in terms of productivity efficiency via continuous manufacturing, and cost reduction via process intensification.