Automation and miniaturization: enabling tools for fast, high‐throughput process development in integrated continuous biomanufacturing

Abstract

Process development in the biotech industry leads to investments around hundred of millions of dollars. It is important to mitigate costs without neglecting the quality of process development. Biopharmaceutical process development is important for companies to develop new processes and be first to market, improve a pre‐established process, or start manufacturing a product available by patent expiry (biosimilars). Laboratory automation enables methodical and standardized process development. Miniaturization and parallelization empower laboratories to screen several experimental conditions and define operating windows for purification processes, improving process robustness. Together, they allow for fast and accurate process development in a fraction of the time and cost of nonminiaturized/nonparallel process development approaches. The most widely used High‐Throughput Screening technique is a liquid‐handling station and microfluidics is taking its first steps in process development. Both are attractive scale‐down tools for the characterization of bioprocesses and allow thousands of experiments to be performed per day. High‐Throughput Process Development (HTPD) has helped to achieve major breakthroughs in process optimization, both for upstream and downstream processing. Continuous processing is the next step in process development which leads to cost reduction, higher productivity and better quality control; the integration of upstream and downstream processes is seen as a major challenge. In this review, we will focus on the state‐of‐the‐art of miniaturized techniques for process development in the biotechnology industry, and how automation and miniaturization drive process development. A comparison between liquid‐handling stations and microfluidics is made and an indication is given of which tools are still lacking for HTPD in the context of Integrated Continuous Biomanufacturing. © 2021 The Authors. Journal of Chemical Technology and Biotechnology published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry (SCI).

Optimization of resource-intensive dynamic systems with a continuous supply of raw materials according to the criterion of minimum use of reserves

“…The authors of paper [1] in this area note that it is important to reduce costs without neglecting the quality of the results of the process. Continuous processing, in their opinion, is the next step in the development of the process, leading to lower costs, increased productivity, and better quality control.…”

“…Summing up their analysis of literature data [1][2][3][4][5][6][7][8][9][10][11], we can conclude that the task of optimizing continuous processes is relevant. However, it is necessary to take into consideration the complexity of the resource-intensive production process with dynamically changing parameters and external economic factors.…”

“…Similar to [1], it is possible to note the prospects of continuous processes in contrast to discrete or discrete-continuous, which make it possible to reduce costs, increase productivity, and improve quality control of products. Taking into consideration the Paris Climate Agreement, described in [3], a new, more energy-efficient approach to the implementation of continuous dynamic processes is proposed.…”

Artificial Intelligence Algorithms Enable Automated Characterization of the Positive and Negative Dielectrophoretic Ranges of Applied Frequency

“…The art and science of miniaturization forms the foundation for the rapid progress of the last 30 years in materials science, computational technology, in communications, and in biotechnology [ 1 , 2 , 3 , 4 ]. In microdevices, from modern transistors to Labs-on-Chip, reduction of the size of the components results in faster operation, cheaper cost per device, reduction in energy budget to manufacture and to operate a device, and higher sensitivity and selectivity for microsensors [ 5 ].…”

Development of an Automated Adsorbent Selection Strategy for Liquid–Phase Adsorption

“…Over the last decades, in the field of process design for biochemical products the interest in automation increased significantly [1]. Automation benefits from shortened process development times, limited need of manual intervention, and lower material consumption.…”