Center for Intelligent Microprocess of Pharmaceutical Synthesis, Department of Chemical Engineering, Pohang University of Science and Technology (POSTECH), Pohang 37673, Republic of Korea.
School of Chemistry and Chemical Engineering, Harbin Institute of Technology, Harbin 150001, Heilongjiang, P. R. China.
Lab Chip. 2024 May 28;24(11):2861-2882. doi: 10.1039/d3lc01097j.
Biopharmaceuticals have emerged as powerful therapeutic agents, revolutionizing the treatment landscape for various diseases, including cancer, infectious diseases, autoimmune and genetic disorders. These biotherapeutics pave the way for precision medicine with their unique and targeted capabilities. The production of high-quality biologics entails intricate manufacturing processes, including cell culture, fermentation, purification, and formulation, necessitating specialized facilities and expertise. These complex processes are subject to rigorous regulatory oversight to evaluate the safety, efficacy, and quality of biotherapeutics prior to clinical approval. Consequently, these drugs undergo extensive purification unit operations to achieve high purity by effectively removing impurities and contaminants. The field of personalized precision medicine necessitates the development of novel and highly efficient technologies. Microfluidic technology addresses unmet needs by enabling precise and compact separation, allowing rapid, integrated and continuous purification modules. Moreover, the integration of intelligent biomanufacturing systems with miniaturized devices presents an opportunity to significantly enhance the robustness of complex downstream processing of biopharmaceuticals, with the benefits of automation and advanced control. This allows seamless data exchange, real-time monitoring, and synchronization of purification steps, leading to improved process efficiency, data management, and decision-making. Integrating autonomous systems into biopharmaceutical purification ensures adherence to regulatory standards, such as good manufacturing practice (GMP), positioning the industry to effectively address emerging market demands for personalized precision nano-medicines. This perspective review will emphasize on the significance, challenges, and prospects associated with the adoption of continuous, integrated, and intelligent methodologies in small-scale downstream processing for various types of biologics. By utilizing microfluidic technology and intelligent systems, purification processes can be enhanced for increased efficiency, cost-effectiveness, and regulatory compliance, shaping the future of biopharmaceutical production and enabling the development of personalized and targeted therapies.
生物制药已成为强大的治疗药物,彻底改变了癌症、传染病、自身免疫和遗传疾病等各种疾病的治疗格局。这些生物疗法以其独特和靶向的能力为精准医学铺平了道路。生产高质量的生物制剂需要复杂的制造工艺,包括细胞培养、发酵、纯化和配方,这需要专门的设施和专业知识。这些复杂的过程受到严格的监管监督,以评估生物疗法在临床批准前的安全性、有效性和质量。因此,这些药物需要经过广泛的纯化单元操作,通过有效去除杂质和污染物来达到高纯度。个性化精准医学领域需要开发新型高效技术。微流控技术通过实现精确和紧凑的分离,提供快速、集成和连续的纯化模块,满足了未满足的需求。此外,将智能生物制造系统与小型化设备集成,为提高生物制药复杂下游处理的稳健性提供了机会,具有自动化和先进控制的优势。这允许无缝的数据交换、实时监测和纯化步骤的同步,从而提高工艺效率、数据管理和决策制定。将自主系统集成到生物制药纯化中,确保符合监管标准,如良好生产规范(GMP),使行业能够有效应对个性化精准纳米医学的新兴市场需求。本综述将重点介绍在各种类型的生物制剂的小规模下游处理中采用连续、集成和智能方法的重要性、挑战和前景。通过利用微流控技术和智能系统,可以提高纯化过程的效率、成本效益和法规遵从性,从而塑造生物制药生产的未来,并实现个性化和靶向治疗的发展。
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