Toward microfluidic continuous-flow and intelligent downstream processing of biopharmaceuticals
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...
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| Published in | Lab on a chip Vol. 24; no. 11; pp. 2861 - 2882 |
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| Main Authors | , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
Royal Society of Chemistry
28.05.2024
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| Subjects | |
| Online Access | Get full text |
| ISSN | 1473-0197 1473-0189 1473-0189 |
| DOI | 10.1039/d3lc01097j |
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| Summary: | 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.
The concept of miniaturized biopharmaceutical downstream processing with AI-controlled continuous flow platforms is described to overcome limitations of conventional processes, potentially accelerating the development of novel biotherapeutics. |
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| Bibliography: | Dong-Pyo Kim earned his PhD in Chemistry from the Temple University, Philadelphia in 1991 and served as a postdoctoral researcher at the University of Illinois from 1991 to 1993. Kim assumed the role of Senior Researcher at the KRICT, South Korea, before his position as a Professor of Applied Chemistry at Chungnam National University (Korea), 1995. In 2012, Kim joined POSTECH, South Korea, as a Professor in Chemical Engineering, and headed up the Center for Intelligent Microprocess of Pharmaceutical Synthesis in 2017. In 2022, Kim assumed the role of CTO at Flow-Medi, while continuing to hold his academic positions. Vikas Sharma currently holds a postdoctoral fellow position within the CIMPS group at the Chemical Engineering department of Pohang University of Science and Technology, South Korea. Vikas earned his Ph.D. in Biotechnology from National Institute of Technology Raipur, India, where his research focused on the production and purification of thermostable enzymes. He then served CSIR-IITR, India, as a Senior Project Associate, and was also awarded the prestigious SERB-NPDF postdoctoral fellowship by the Government of India. His research interests lie in developing innovative solutions for upstream and downstream processing of biopharmaceuticals utilizing microfluidics and scale-up modules. Jeong-Un Joo graduated with a BSc in chemical engineering from Ajou University, South Korea in 2019. He joined Professor Dong-Pyo Kim's research group in 2019 to begin his graduate studies. His research area focuses on the design and development of microfluidic modules for chemical (bio)synthesis and purification. Additionally, he aims to build an integrated continuous platform by consolidating individual modules and implementing integrated real-time analysis to enable self-optimization. Ji-Ho Kang graduated with a BSc in chemical engineering from Pohang University of Science and Technology (POSTECH, Korea) in 2016. He received his PhD in chemical engineering from POSTECH in 2024, with research focusing on microfluidic based ultrafast API synthesis. Ji-Ho is currently serving as a postdoctoral researcher within the CIMPS group at POSTECH and his research interest lies in the development of drug conjugates using flow chemistry. Lei Wang received his PhD Degree from Harbin Institute of Technology (HIT), China, in 2015, with further studies at the University of Maryland (College Park), under the supervision of Prof. Zhihong Nie and the University of Leeds, under the supervision of Prof. Stephen Evans. After working as a Marie Curie Fellow in Prof. Samuel Sanchez's group at IBEC, Spain (2017-2019), he moved back to China and was appointed as Professor at HIT. Currently, his research interest includes the application of biomaterial self-assembly in the fields of micro/nanomotors, biosensors, bioenergy, and biomimetics. Amirreza Mottafegh holds a BSc in chemical engineering from Sharif University of Technology, Tehran, Iran. He has been a graduate student at POSTECH, South Korea, in Professor Dong-Pyo Kim's group since 2021, and specializes in the design and development of automated, autonomous microfluidic platforms. His research focuses on integrating individual modules for continuous processing, enabling the creation of self-optimizing systems for the synthesis of active pharmaceutical ingredients (APIs) and nanoparticles for drug delivery systems. This approach allows for real-time analysis and control of the processes, leading to higher efficiency and precision. ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 ObjectType-Review-3 content type line 23 |
| ISSN: | 1473-0197 1473-0189 1473-0189 |
| DOI: | 10.1039/d3lc01097j |