Osaka

Osaka Site - Striving Towards the Future

Strict and Unwavering Quality Control

The quality of pharmaceuticals, which affect human lives, must be manufactured as designed. For this reason, manufacturing control and quality control of drugs are strictly enforced. In addition to being manufactured following GMP (Good Manufacturing Practice: Standards for Manufacturing and Quality Control of Pharmaceuticals) established by Japan, Takeda also manufactures in accordance with the GMP of the countries where it sells its products.

Starting with the acceptance of raw materials and packaging materials, we can finally ship after passing multiple inspections and tests, such as sampling inspections in each manufacturing process, product appearance inspections, physical and chemical tests, microbiological tests, and packaging product tests. Various checks are repeated to ensure that our products can be used with peace of mind.

In 2021, we received regulatory approval for Alofisel, our first stem-cell therapy product for Takeda, Japan, a product that utilizes the latest technology in its manufacturing process. For example, the isolator, which was introduced for the first time in Alofisel's manufacturing network, enables rapid sterilization (ultra-fast decontamination) and maximizes product quality.

We have also established a dedicated logistics system that enables administration within 72 hours. Thanks to the efforts of the team in charge, this Alofisel manufacturing technology was successfully transferred over quickly and efficiently from the Madrid Site in Spain, where the product was originally produced, even during the pandemic period.

Supported by Technology and People

The Osaka Site also operates a new manufacturing facility for Leuplin, one of Takeda's major oncology products. State-of-the-art equipment, such as isolators (manufacturing equipment that can physically separate sterile products from workers who would cause contamination), automatic inspection machines equipped with deep learning functions, robots and cobots (collaborative robots), and other technology have been introduced.

This has helped to reduce human error, implement electronic data and document management systems, and incorporate dashboards for process monitoring and big data analysis to improve manufacturing efficiency, quality, and compliance. Furthermore, as part of our investment in our people, we are focusing on ensuring high-quality conversations that build relationships of trust and lead to growth and results, reskilling, and fostering a learning culture.

Aiming to Be an Environmentally Friendly Site

In 2000, we obtained ISO14001 certification, an international standard for environmental management systems. We are strengthening our environmental management system and working on continuous improvements, such as waste reduction (zero emission) activities.

We are striving day and night to create a pollution-free and clean local environment by adopting a thorough system for treating wastewater from the site in the wastewater treatment layer, reducing nitrogen oxides by improving boiler combustion and preventing increases in water and air pollution.

We have also developed and utilized DENSKE, a dashboard that allows anyone to check the status of electricity and water consumption, and we are making progress toward achieving our sustainability goals.

Sharing the Future as a Member of the Local Community

At the Osaka Site, we want to be a presence that is always trusted by the local community. As a disaster prevention measure for large-scale disasters, etc., we have registered as an Osaka City Tsunami Evacuation Building. We regularly plant greenery in vacant lots on the site and clean up the surrounding area.

Furthermore, we aim to create a site that can coexist in harmony with the future by asking residents to become "environmental monitors" and conducting surveys on noise and odors on-site.

Aiming to Become a “Site of the Future”

The Osaka Site is taking the lead in the digital transformation (DX) of our manufacturing, aiming to become a “Connected & Predictive Site” by utilizing data to predict and avoid possible deviations and risks in the manufacturing process, supply, quality, compliance, and efficiency.