Chugai Pharmaceutical is currently promoting companywide DX to achieve the targets of its new growth strategy Top I 2030. The company is focusing on innovative drug discovery and aiming to increase efficiency in bioprocess development using digital technologies.. These activities are gaining particular momentum at the Pharmaceutical Technology Division. In this article we speak to three individuals who are engaged in bioprocess development using digital technologies. They tell us where the company is currently at in terms of digitalization and their future hopes.

(Interviewee: Nakajima, Chen, Nonaka)

*Reproduced from Chugai Pharmaceutical’s official Talentbook page (https://www.talent-book.jp/chugai-pharm) Article details and employee positions are current as of November 2023

Achieving a Data-driven Process Development Cycle

In 2020, Chugai Pharmaceutical formulated the CHUGAI DIGITAL VISION 2030, aiming to “transform its business using digital technologies to become a top innovator in providing healthcare solutions that change society.” In this sense, the company has been ahead of the curve in the pharmaceutical industry in its promotion of DX. Moreover, the company is proactively implementing digital technologies in its development of manufacturing processes for biopharmaceuticals.

 

Nonaka: Pharmaceutical process development involves development of efficient and safe mass-production methods for new pharmaceuticals based on lab data.

Previously, process development was predominantly conducted through wet experiments in the lab, typically taking around 10 years or longer from concept to market launch.

In today's competitive environment, we face key challenges: boosting success rates, cutting development time, and lowering costs. To address these, we're embracing digital technologies. One of our strategies is to shift parts of our process development from traditional wet lab experiments to computer simulations. By doing this, we aim to make our operations more efficient and sophisticated.

 

Nakajima, Nonaka, and Chen belong to the API Process Development Department, which is in charge of process development for bio drug substances. Nakajima engages in the development of cell culture technologies, while Nonaka and Chen are involved in the development of purification technologies.

 

Nakajima: I have been developing a cell culture simulation technology as a DX project. Our group is responsible for the development of cell culture processes and related technologies toward manufacturing of bio drug substances. One of our goals is to reduce the labor costs and experimental costs for process development. In order to achieve the goal, we are focusing on modeling of cell culture dynamics by applying hybrid model that combines mechanistic model and machine learning model. The project has just started and we are considering the best approach through the discussion with internal and external experts and conducting a trial-and-error cycle.

In another project, I am working on the development of in-line Raman spectroscopy. Cell culture process development normally requires off-line sampling for measurement of various parameters by using multiple devices, but in-line Raman spectroscopy enables measurement of all parameters with a single sensor. If we can put the Raman spectroscopy to practical use, we will be able to remotely access the data from outside the lab without off-line sampling in the lab.

We hope that the time this frees up can be used for other research and development activities. Recently, we have been developed process control method using cell culture information obtained from in-line Raman spectra. We are now preparing a patent application.

 

Nonaka: I have been working with employees from various departments on a DX project to promote the digitization and optimization of experiment records from across the Pharmaceutical Technology Division. When I first joined the company, experiment records were written on paper and stored in physical archive, but my predecessor introduced electronic experiment notebook. I joined the DX project to take over this initiative. In addition to digitizing experiment records, we have introduced an additional function to integrate these records with data on experimental equipment, reagents, and sample information. In 2022, we completed the development and introduction of a series of systems, which has enabled us to fully digitize our R&D operations.

Since 2023, we've been developing a new digital platform to centralize our data management. Previously, data was scattered across departments in various formats, requiring manual compilation. Our new system aims to make all data easily accessible in one place.

This isn't just about organization; it's about boosting our R&D capabilities. By centralizing our data, we're enabling advanced simulations and modeling techniques, which should accelerate our development processes.

In essence, we're transitioning from basic digitization to fully leveraging our data's potential.

 

Chen: I work on purification process development in the same group as Nonaka-san. Specifically, I work on the development of modeling technologies to accelerate process development, as well as the development of digital tools to improve operational efficiency. This includes developing models to predict the behavior of antibodies and impurities, as well as developing techniques using machine learning to predict buffer compositions for membrane filtration processes by utilizing past experimental data.

In addition, I’m also involved in building databases and infrastructure to utilize these data, as well as the development of web applications.

Excitement and Fulfilment in Promoting Process Development DX at a Leading Pharmaceutical Company

The year before it announced the CHUGAI DIGITAL VISION 2030, Chugai Pharmaceutical established the digital strategy promotion department. In addition to its reinforcement of the company’s digital platforms, the department’s efforts to reform the company’s culture are beginning to bear fruit.

 

Nakajima: Our managers are very proactive for DX , so we are able to move forward easily with their understanding or agreement.

 

Nonaka: In addition to us three, there are many more employees within the API Process Development Department working on DX projects. Aiming for greater efficiency and automation, the department as a whole is very proactive about introducing high-level analysis technologies that were previously difficult to use. I think we are developing a culture which is very supportive of DX initiatives.

 

On the other hand, it is precisely because we are at the forefront of the industry that we are having to work so hard.

 

Nakajima: I have been involved in both projects from the start point. DX related theme often requires digital infrastructure or platforms. We therefore had to collect the information regarding system, equipment and software, compare the information, and select the best option. Difficult thing is to ensure stable operation after setting up the system and software, as the projects are completely new things in the organization.

 

Nonaka: Developing a data platform from scratch has been challenging. We are working quickly to develop prototypes and collaborating with DX specialists from other departments.. Our ability to use an agile in-house development approach is one of our biggest strengths.

 

Chen: In the process of building the database, we are struggling with the task of connecting core systems from across the company. Moreover, to advance technological development by accelerating data utilization, data coordination with our strategic partner Roche is also essential. The challenges we need to solve are diverse and wide-ranging.

Chugai Pharmaceutical has been a leader in the domestic pharmaceutical industry with its proprietary technological capabilities in science and drug discovery. Nakajima, Nonaka, and Chen say that implementing DX into the company’s manufacturing process development is highly rewarding.

 

Nakajima: We have a large number of new drug candidates as an R&D-based biopharmaceutical company. As we work to maintain and improve our world-leading technological capabilities and proceed with manufacturing process development in an efficient manner, bringing DX into our operational processes, such as through Nonaka and Chen’s creation of a data usage platform, is a pressing challenge. The work we are doing is very rewarding.

 

Nonaka: As Nakajima-san says, we have advanced our DX projects with a clear objective. If, for example, we can shift some of our process development operations into simulations, we will be able to significantly reduce the time and costs required for development. This in turn will enable us to deliver new drugs to patients even more quickly.

Chugai Pharmaceutical boasts one of the most innovative development pipelines in Japan. As a Chugai Pharmaceutical employee, my motivation is to respond to unmet medical needs.

 

Chen: It is hugely rewarding when the results we predict through our modeling technologies are applied to the manufacturing process and are consistent with the actual results. Moving forward, I hope to make further progress with DX, enhance the value of data, and expand the scope in which it is used in process development and R&D.

Different Qualities from Different Perspectives. Our Reasons for Working at Chugai Pharmaceutical

All three employees came to join Chugai Pharmaceutical along completely different paths. And all three enjoy working there for different reasons.

 

Nakajima: Since forming its strategic alliance with Roche, Chugai Pharmaceutical has benefited from exclusive domestic sales rights for Roche’s revolutionary new drugs, which in turn has given the company a stable revenue base. This has allowed for focused investments in our unique technologies and drug discovery activities, and an environment that is tolerant of innovative initiatives. This environment is incredibly important for R&D. I feel very fortunate to be able to work in this positive cycle.

 

Nonaka: I started out working on purification processes for about a year. Then, I was appointed the leader of our digital infrastructure team. One thing I really like about our company is how they handle job assignments. They really listen to what each employee wants and try to match assignments with our career goals. It's great to see the company focusing on our individual growth and development.

Chen: As part of our digitalization and technology development activities, every three months we hold meetings with specialists from Roche Group in Germany and the US. It is always inspiring when we exchange information and expertise.

 

Although these three individuals are incredibly busy working on the frontlines of process development, they say that they have a surprising degree of freedom in the way they work.

 

Nakajima: In our department, we make use of a super flex time system without any core working hours. Within the scope of this system, we are able to work with real freedom. Systems like these are also regularly improved in line with social trends and employee feedback. There has also been an increase in the number of employees working remotely since the COVID-19 pandemic. The company is very flexible. Today, for example, I worked from home to look after my child who was feeling poorly.

 

Nonaka: While of course I come into the office when it is more efficient to communicate to my colleagues face to face, I spend about three days a week working from home. Even post-pandemic, many of our employees are working remotely. The distinction between working at the office and remote work is being actively discussed as a means to carry out tasks more efficiently. There are ongoing debates about how to appropriately balance and utilize these two work styles.

 

Chen: For a while, I even worked from my home in Taiwan. Regardless of nationality or location, the company provides us with flexible options to work in ways that match our lifestyles.

A Better Future for Healthcare Through Digital Technologies

What type of human resources are required for the company to promote use of digital technologies and create new value? What characteristics are required to provide healthcare solutions that can transform society? We ask the trio for their thoughts.

 

Nakajima: Innovation requires personnel with varying expertise and skills. Not only will we welcome people who have majored in biology, we would actively welcome people with experience in different industries. There is without doubt a place in the company for people with the right ambition, even if they have no direct experience with pharmaceuticals or related areas.

 

Nonaka: At our company, we are not only looking for data scientists and data engineers like Nakajima-san and Chen-san, but also for talent who can plan and promote digital projects. I had no experience in digital technology development or DX project promotion myself, but at Chugai Pharmaceutical, there are opportunities to take on new challenges and grow. We look forward to meeting people who are skilled in digital technologies that are important for DX in process development, as well as those who have a positive attitude towards change.

 

Chen: As we aren’t a dedicated IT department, our ideal candidate at the API Process Development Department is someone who can combine their expertise in bioscience and data science. In our department, I think the ideal candidate must also be willing and proactive about constantly taking on new challenges.

Nakajima, Nonaka, and Chen have played key roles in implementing DX in process development since they joined the company. Their desire to streamline and sophisticate process development remains unchanged.

 

Nakajima: The company has formulated the Top I 2030 growth strategy and set out the organizational targets to achieve it. For us, it will be important to create a vision for process development and adopt a well-balanced stance that makes use of both the backcasting and forecasting approach. While constantly updating our goals, we will examine how to get closer to achieving them.

 

Chen: The Group’s slogan for technology development is “Create a Global Standard.” We aim to establish a new global standard in process development by aligning with 'TOP I 2030' in all aspects, including precision, speed, and the application of digital technologies.

 

Nonaka: DX (Digital Transformation) is key driver to achieving our "TOP I 2030". We will strive to make use of digital technologies to achieve efficient, high-level process development and in turn quickly bring innovative new drugs to market. To make this big change happen, we're working on DX projects. We're excited to team up with many colleagues to push these projects forward.