Yamamoto works in Digital Science within the Analysis Research Department of the Pharmaceutical Technology Division. He leads research and development in pharmaceutical processes using fluid simulation technology and contributes to the investigation, development, and evaluation of advanced technologies for implementation. From Yamamoto’s perspective, shaped by experience across multiple industries, what distinguishes pharmaceutical companies, particularly Chugai Pharmaceutical? This article explores the transformative potential of digital technology in pharmaceutical process development.

*Reprinted from Chugai's official talentbook (https://www.talent-book.jp/chugai-pharm). The descriptions and affiliations are current as of September 2023.

Accelerating Access to Effective Medicines: Enhancing Pharmaceutical Process Development through Fluid Simulation

"My group supports the development of drug manufacturing processes and testing methods through digital technology. I focus on pharmaceutical process research, development, and troubleshooting using fluid simulation, mechanical engineering, and chemical engineering.

Scaling up from laboratory to manufacturing scale is essential for delivering medicines to patients. However, chemical reaction rates are significantly influenced by agitation conditions such as the impeller’s shape, number, and rotation speed.

Observing fluid behavior directly inside tanks is difficult. Therefore, we use fluid simulation technology to visualize and analyze flow, mixing, and reaction progress within the tanks, enabling process improvement and optimization."

 

Occasionally, high-precision analysis is required within limited timeframes. Yamamoto notes that such circumstances test a researcher’s experience and technical expertise.

 

"Fluid simulation is time-intensive. To obtain timely and accurate results, we must narrow down the relevant conditions using accumulated data, such as experimental formulations. We pay particular attention when unexpected outcomes occur during scale-up and suspect agitation-related causes."

 

Beyond process development, Yamamoto is also engaged in the implementation of emerging technologies.

 

"New methods, such as those that enhance simulation efficiency using machine learning, are constantly emerging. Relying solely on traditional techniques would hinder progress. I actively pursue the latest developments, assess and validate them, and continually update my skills and knowledge. I also develop simulation software through programming and present results at academic conferences and in publications."

 

Yamamoto has helped reduce development time and cost by applying his specialized knowledge and advanced technical skills. He finds great satisfaction in his role at Chugai Pharmaceutical:

 

"Chugai has a broad pipeline of new drug candidates and numerous ongoing projects. With new factories and facilities being established, simulation requests are continuous. There are many opportunities to make a meaningful impact, and I feel a deep sense of fulfillment in contributing to patients battling illness."

Entering a New Industry: Applying Simulation Technology to Expand into the Pharmaceutical Field

After specializing in nuclear engineering and researching nuclear fusion plasma through magnetic confinement simulations, Yamamoto began his career at a major steel manufacturer. There, he applied his simulation technology expertise in a practical setting.

 

"I chose to pursue simulation professionally because I was drawn to the elegant visuals produced through analysis. I was also interested in fluid dynamics, which shares commonalities with plasma, and thus I engaged in research and development related to steel manufacturing processes using thermal fluid analysis.

 

My responsibilities included simulating molten iron flow and chemical reactions in furnaces and making recommendations based on those results. I contributed not only to equipment installation and problem resolution but also to coating steel plates for automotive use with molten zinc."

 

The steel industry presents many scenarios requiring simulation, and many experts are active in the field. Although Yamamoto found this work rewarding, he began seeking new challenges and encountered an opportunity at Chugai Pharmaceutical.

 

"After over a decade in the steel industry, I never expected fluid simulation to be relevant in pharmaceuticals. However, I was attracted by the chance to apply my accumulated knowledge in a setting with relatively few specialists, offering room for addressing new challenges.

The corporate culture was also decisive. Throughout the recruitment process, I sensed a consistently welcoming atmosphere and a flat organizational structure, which ultimately led me to join."

 

Yamamoto faced significant challenges upon entering the unfamiliar pharmaceutical field. He overcame them with the support of his supervisor.

 

"My first obstacle was my lack of pharmaceutical knowledge and unfamiliarity with the terminology. My supervisor was instrumental in my transition, assigning manageable tasks and regularly creating opportunities for me to ask questions. We still hold one-on-one meetings every other week."

 

Despite the challenges, Yamamoto frequently draws on his past experience and finds his work deeply rewarding.

 

"Interviewing staff to grasp the overall project scope, analyzing issues, and proposing optimal solutions are responsibilities I had in my previous role. Although steel manufacturing and pharmaceuticals produce vastly different products, the underlying approach to problem-solving is similar. My prior experience is directly applicable.

Also, as the sole thermal fluid analysis specialist in the company, I handle all related simulations. The responsibility is significant, but it brings an equally significant sense of accomplishment."

Making an Impact Through Troubleshooting and New Technology Implementation: Underpinned by Chugai Pharmaceutical's Free Corporate Culture

Yamamoto reflects on a particularly memorable experience since joining the company:

 

"There was an instance where a problem arose in the drug manufacturing process, and we utilized simulation technology to investigate the issue, which ultimately led to its resolution. This was the first time simulation technology had been used for problem-solving in this context, and it became a catalyst for greater attention within the department."

 

He also achieved significant results in implementing new technology:

 

"I learned that pharmaceutical companies in Europe and the U.S. were actively implementing software capable of high-speed calculations, and I proposed its adoption internally. I led the implementation process by liaising with overseas agents and meeting with software developers for verification and evaluation."

 

Yamamoto attributes his ability to act freely to Chugai Pharmaceutical’s corporate culture, which he greatly values:

 

"When I consulted my supervisor about implementing the software, approval was granted immediately. I am also permitted to use self-developed software for work, providing me with considerable discretion and broadening my scope of responsibilities.

Another advantage of Chugai Pharmaceutical is its low communication cost. Interaction is smooth not only with supervisors but also with staff outside my group via chat tools, which accelerates work rotation and boosts productivity.

Furthermore, Chugai Pharmaceutical is actively promoting DX [digital transformation], which is steadily gaining traction in the field. When I discuss simulation technology, the response is positive, and I receive numerous inquiries. This creates a highly conducive work environment."

Pioneering the Future of Pharmaceuticals with Digital Innovation: Breakthroughs Made Possible Only at Chugai Pharmaceutical

Looking back, Yamamoto acknowledges his initial anxiety about transitioning between industries. He encourages technicians and researchers who may have reservations about working with fluid simulation technology:

 

"The sense of social contribution I experience is unique to Chugai Pharmaceutical, especially given its numerous new drug candidates. The company provides an environment where one can work with fluid simulation technology while having significant autonomy, making it an ideal workplace for those seeking meaningful work.

Thermal fluid analysis technology is highly versatile. With the right knowledge, experience, and the ability to understand others' perspectives, as well as the insight and drive to comprehend their true needs, individuals from diverse industries can effectively apply their previous experiences and thrive in this field. Pharmaceutical knowledge can be acquired later. While changing industries may require courage, I encourage others to embrace the challenge."

 

Chugai Pharmaceutical has developed CHUGAI DIGITAL VISION 2030, a comprehensive strategy to promote DX and position the company as a leading innovator. This vision aims to revolutionize Chugai’s business through digital technology and deliver healthcare solutions that transform society. Aligning with this vision, Yamamoto is committed to continuing his involvement in the development and enhancement of pharmaceutical processes through fluid simulation technology.

 

"I strongly resonate with our company’s vision of achieving efficiency and innovation by reducing time and costs in pharmaceutical processes through digital technology. I believe that digital technologies, such as fluid simulation, should be applied to an even broader range of applications. I hope to leverage the scientific and technological expertise our company has cultivated, combined with digital tools, to provide solutions that can truly change society.

I also aim to focus on the implementation of cutting-edge digital technologies. In recent years, there has been growing discussion within the pharmaceutical industry regarding the potential use of digital twin technology, which replicates real-world phenomena in virtual environments. I aspire to contribute to this ongoing process, where new technologies gradually become mainstream and expand the possibilities within the pharmaceutical field."

 

The fusion of science, technology, and digital innovation opens new pathways for the future of pharmaceuticals. With the aim of realizing unprecedented breakthroughs, Yamamoto’s journey continues into a new chapter.