According to a report by The Nikkei on October 30, Astellas Pharma, Inc. has automated the cultivation of iPS cells (induced pluripotent stem cells) using dual-arm robots. The company has applied to regulatory authorities for the use of robots in pharmaceutical manufacturing, with the goal of providing drugs for clinical trials by 2026. If manual operations are replaced by machinery, error rates could be reduced, increasing the success rate of iPS cell cultivation by more than 60% compared to current levels. Once commercialized, this will facilitate the broader application of iPS cells.

The robot "Maholo" used by Astellas was developed by the Robot Biology Institute (RBI), a subsidiary of Yaskawa Electric Corporation and an emerging company established by the National Institute of Advanced Industrial Science and Technology.

Maholo smoothly moves both arms, using a pipette to inject solutions and transfer cell culture plates. It is said that compared to single-arm robots, this dual-arm robot can reproduce human movements within a smaller space.

After iPS cells are cultured and proliferated, they need to differentiate into nerve cells or blood cells according to different therapeutic purposes. This work relies heavily on the researchers' proficient manual skills but is also prone to errors. Due to subtle differences in conditions such as temperature, there is a risk that the differentiated cells may not match their intended purpose.

Even for extremely subtle movements like a slight hand tremor, Maholo can maintain a certain angle and speed to correctly operate the tool, thereby significantly increasing the success rate of cell culture.

If robots that can work 24 hours a day, 365 days a year are used, high-precision experiments can be repeatedly conducted, comparing more laboratory culture conditions. Combined with artificial intelligence, it may be possible to complete experiments at a scale hundreds or even thousands of times greater than before within the same time period.

Once cell culture begins, it is necessary to create a suitable environment to promote metabolism, which sometimes requires continuous work for weeks or even months, with no breaks on weekends. However, with the introduction of robots, researchers can monitor remotely, thereby reducing the need for commuting.

Astellas Began Using Robots for New Drug Development with iPS Cells as Early as 2017. In 2023, the Company Started Validating the Feasibility of Robot-Involved Drug Manufacturing. Shuji Yamaguchi, Director of the Active Pharmaceutical Ingredients Research Laboratory, Said: "The R&D Cycle Will Be Shortened by Several Months, Allowing Products to Reach the Market Earlier."

Cell therapy is one of the key areas of development for Astellas. In addition to conducting cell-based drug trials for the elderly with "age-related macular degeneration," the company is also advancing related research in autoimmune diseases.

Cell drugs manufactured by robots still need regulatory approval before they can move into clinical use. According to insiders at Astellas, "Cell differentiation is usually done manually, with few examples of robotic automation."

To this end, the company will consult with the U.S. Food and Drug Administration and Japan's Pharmaceuticals and Medical Devices Agency, aiming to supply new drugs for clinical trials manufactured by Maholo around 2026.

Other pharmaceutical giants are also accelerating the introduction of robots. In October, Chugai Pharmaceutical launched a demonstration experiment using robots at its research facility in Yokohama City. By collaborating with Omron, the company aims to automate processes such as cell culture. The robot will automatically patrol the research room and transport experimental reagents to equipment like microscopes, centrifuges, and refrigerators.

The movement of cell culture plates has been experimentally taken over by robots. Previously, Chugai Pharmaceutical introduced a system that automates the gene replication process, and by working at night, it reduced the time required to generate antibody genes from the previous 5 days to 3 days.

It is said that drug development usually takes more than ten years, with a success rate of only one in thirty thousand. Shoichi Negishi, Executive Director of Deloitte Consulting, who is familiar with the application of digital technology at drug development sites, stated: "The use of robots and artificial intelligence will enhance the level and efficiency of drug development. If manpower can be saved, it is expected to increase the possibility of technical innovation through collaboration among researchers."