SustainabilityProviding high-quality pharmaceuticals to patients around the world

Takasaki Plant is a state-of-the-art biopharmaceutical production plant with production lines both for investigational drugs and for launched products. It complies with the international standard Good Manufacturing Practice (GMP). Our manufacturing and quality functions work closely together to produce high-quality pharmaceutical products that customers can use with confidence. Our teams handle a wide range of verification work-from raw materials to manufacturing processes, testing and inspection, and final shipping decisions-before our products are sent around the world.

Drug substances for biopharmaceuticals are produced by mass cultivation of genetically engineered animal cells and microorganisms. The system for this process involves a large tank (reactor) with a capacity of 10,000 liters. However, maintaining productivity while scaling up from lab scale to large-scale production is not a simple matter. The Takasaki Plant has established a system that uses a large-scale commercial production process to ensure stable production and high productivity. This involves precise, smooth technology transfer in close cooperation with the adjacent Bio Process Research and Development Laboratories. Key to enabling this are our high level of experience, accumulated from the many biopharmaceuticals we have produced over the years, and the cutting-edge technological capabilities we have developed through that experience.

We are advancing several capital investment projects in the Takasaki area. The largest of these is the construction of a new seven-story building to accommodate our quality teams. The total investment of this project is expected to be \14 billion.
Previously, our quality control and quality assurance functions were dispersed throughout the Takasaki area. By gathering these teams together in the new building, we aim to improve operational efficiency and enhance communication, ensuring fast, accurate execution of operations. We will also introduce state-of-the-art analytical equipment with a view to addressing future regulation changes. This will help us to ensure a stable supply of high-quality biopharmaceuticals.

The most important elements for ensuring a stable supply are stable plant operations and precise demand forecasting. As well as investments in IT and digital and in people development aimed at optimizing factory utilization, Kyowa Kirin is also focusing on supply chain management (SCM). The number of countries in which global strategic products such as Crysvita are sold is steadily increasing, and overseas sales are growing every year. This has led to a growth in the number of entities involved - from manufacturing sites to distribution centers and other outsourcing partners-which has increased the complexity of our supply chain. The SCM Function is responsible for accurately monitoring and controlling this complex situation. Their task is to ensure that Kyowa Kirin’s pharmaceutical products reach the patients who need them, when they need them, and in precisely the quantity needed.

Pharmaceuticals are products that directly affect human lives. At a pharmaceutical company, quality is the responsibility of each employee. Without robust quality and compliance, we cannot earn the trust of patients, healthcare professionals, or national regulatory authorities. Kyowa Kirin’s Global QA Function is responsible for confirming that all processes involved in the production of products and investigational drugs are conducted properly and in compliance with relevant laws and regulations. In this way, the function fulfills its role of ensuring that there are no problems with the quality of the drugs delivered to patients.

We have been steadily strengthening our global quality assurance system since 2019, when we began globalizing our business in earnest with the launch of global strategic products in Europe and the United States. As part of this effort, we formulated the Kyowa Kirin Group Quality Policy and the Global Quality Roadmap to 2025. In one particularly important measure, we have adopted an enterprise/electronic quality management system (eQMS). This system is scheduled to be fully operational in 2022.
The scope of our quality assurance operations covers a wide range of areas, from deviation control, corrective action/preventive action (CAPA), and training to document management, auditing, supplier management, and change management. With the introduction of this system, we will switch from traditional paper-based operations to fully electronic processes. This will enable us to meet, to a globally consistent standard, the requirements of relevant laws and regulations in each country.