Initiatives of the Technical Center that give shape to quality

At university and graduate school, I majored in virology and performed many analyses using HPLC (High-Performance Liquid Chromatography) as an analytical instrument as part of my research. After joining the company, I engaged in analytical evaluation of IV solutions, which allowed me to leverage my university experience, and I felt this job suited me.

After transferring to the pharmaceutical research group, I have been working on pharmaceutical research for external medicine, supporting overseas applications, and providing support to manufacturing and sales. Our work covers a wide range: in pharmaceutical research, in addition to formulation design studies, it involves selecting and evaluating raw materials, containers, and packaging. In the case of contract manufacturing, we also need to negotiate technical matters with the contractors. As a leader, my main duties are management—confirming direction and schedules and providing consultation as each group member advances their work on various themes.

Even now, as the person responsible for usability engineering in a design and development project underway on a certain theme, I am examining and evaluating specifications related to the safe use of the development product. The work is demanding, but it fosters an attachment to the products, and being able to hear voices from the front lines of medical institutions where our products are actually used gives me a tangible sense that we are contributing to people’s lives and health, which makes it highly rewarding.

After graduating from a university in China, I came to Japan and majored in life sciences in graduate school. In the Overseas Technology Department, where I was assigned when I joined the company, I provided various technical support to overseas subsidiaries, and knowing Chinese as well as other languages proved highly beneficial.

Currently, I belong to the Manufacturing Technical Department, where I am responsible for evaluating domestic and overseas manufacturing plants for ethical drugs and consumer products, as well as development work related to materials. Our company has manufacturing plants in 13 countries/regions, such as South Asia, Southeast Asia, Arabia, and China, and when promoting plans such as the introduction of new production lines or construction of new plants at those sites, we must adhere to Otsuka Pharmaceutical Factory’s quality policy.

However, more often than not, people in those countries have perceptions of quality that differ from those in Japan. Therefore, it was essential to patiently continue communication while accepting the differences in cultural background, to have them understand our way of thinking, and to steadily embed it.

Now, I have shifted my focus to tasks such as addressing important technical issues at our four domestic plants, improving the department’s environment, and promoting smoother information sharing, but the importance of communication remains a central theme for me.

Assigned to the Pharmaceutical Technology Department when I joined the company, I handled everything from developing disinfectant formulations to filing applications. Subsequently, as a new business for our company, we began a challenge in the area of what is referred to as regenerative medicine. I joined as a member of the new team focused on that field.

In my case, although my undergraduate was in engineering, I majored in molecular biology in graduate school, and after joining the company I moved into formulation development, a completely different field, so I’ve always been challenging myself with something new. Furthermore, I am now working in a truly unknown area that is on a different level from anything I’ve done before.

One example is a bioartificial islet for diabetes treatment. It is encapsulated porcine islet cells—porcine islet cells enclosed in capsules—and a very unique product that fuses the distinct functions of “capsules” and “regenerative medicine”. It has attracted worldwide attention as a therapeutic for diabetes, and we have pushed development so we can deliver it as soon as possible.

Design, manufacturing considerations, and application responses for such products were all things no one on the team had experienced, so every day was a process of trial and error. Of course there were failures, but for that very reason, I’m gaining much knowledge and inspiration through the work. Everything is fresh to me and I find it very rewarding.

At the National Institute of Technology, I pursued a course in applied biological chemistry and conducted research leaning toward agriculture, such as methods for ripening persimmons. For my first 10 years at the company, I worked in the Manufacturing Technical Department’s Kushiro Satellite Office located at the Kushiro Factory in Hokkaido, engaging in tasks such as launching formulations for Elneopa IV solutions for high-calorie nutrition and Elneopa NF IV solutions with improved formulations for vitamins and trace element.

After that, I transferred to my current department, where we design and develop environmentally-conscious IV solution bottle containers and packaging materials, and examine manufacturing technologies for their industrialization. Specifically, we develop resin formulations used for containers and packaging materials and perform shape design and evaluation utilizing strength and functionality simulation analyses by CAE (Computer-Aided Engineering).

In addition, aiming for industrialization, we examine manufacturing conditions that enable stable production of these products during mass production and evaluate sterilization methods and conditions. Not only that—and we consider this the most important—we ask people at medical institutions to handle the development items and interview them about their impressions, the feel of the products when they actually touch them, and the sensation when using them. I believe that directly listening to healthcare professionals and applying their feedback to product creation is one of Otsuka Pharmaceutical Factory’s strengths.

Mitsumoto: Our company is an IV solutions company. With a 50% share of the market, I think Otsuka’s IV solutions are often used in medical practice. IV solutions go directly into patients’ blood vessels. Therefore, they must be of a quality that can be used with confidence. Quality is the lifeblood of Otsuka Pharmaceutical Factory and every employee is deeply committed to that.

Tsubakiyama: I feel that the containers that hold the formulations reflect the company’s thoughts on quality. Our products are sturdy and easy to hold, with attention also paid to ease of use. When my own child was hospitalized, I felt reassured that our products were being used.

Han: By applying color printing to the container body and labels, visibility improves, helping prevent mix-ups on site. Senior employees took that kind of technology to China for the first time, which I heard was extremely well received. As a result, a virtuous cycle has emerged for the business as well.

Fujiwara: We are currently focusing on initiatives for containers that are also environmentally friendly. One of these initiatives is reducing the wall thickness of bag products. If we use film that can maintain strength even at a thinner thickness, we can reduce the amount of resin material used, ultimately lowering the environmental burden. To that end, we are not relying solely on material manufacturers; we ourselves are researching new resins.

Fujiwara: Back when I worked at the Kushiro Factory, my main job was to think about how to manufacture the formulations and containers within the existing production lines. It involved setting the conditions to translate the formulation developed by the Pharmaceutical Technology Department and the container manufacturing methods developed by the Manufacturing Technical Department into actual production.

To that end, we maintained close daily communication with departments at the Head Office. Even while in Kushiro, I never felt that Tokushima was far away.

Mitsumoto: To maintain the stability of IV solution formulations, the way containers are made and the technologies for performing stable manufacturing at the factory are important. For that, the Pharmaceutical Technology Department, the Manufacturing Technical Department, and the factory’s satellite offices need to come together as one team to work on development, so it is important to have an environment where such collaboration can be conducted closely.

Tsubakiyama: The development period for products is relatively short, but once launched, products continue to be used for ten, twenty, and sometimes many more years. In other words, compared with the development period, the product lifespan is overwhelmingly longer. The role of the Technical Center does not end when a product is launched; it remains important to address various issues thereafter and to minimize post-launch problems.

Here, all departments are gathered on a single floor, so the openness is excellent, and the speed of all responses is a strength.

Han: In communication and collaboration, openness is essential, and this is not limited to the Technical Center. At this company, we receive strong support when we want to take on challenges. For example, when I expressed a desire to experience other new kinds of work, my supervisor took that into consideration and arranged my assignments. I believe this kind of corporate culture is leading to the successive emergence of new products and new technologies.

(Affiliated departments and job titles current as of the time of the interview.)