Sustainability in business practice

Astellas implements access programs throughout the medicinal product lifecycle to provide patients with sustainable access to our innovative therapies. Healthcare professionals can submit a request for Astellas medicinal product on behalf of their patients using our Access to Medicines Request Platform. 

Click here to access the request platform. 

Through these efforts, we strive to make it easier for patients and their care partners to participate in clinical trials so that we can obtain trial results with scientific significance and meaningful outcomes for patients. 

Doping is an issue closely related to abuse and misuse of medicinal products in sports. It is a serious priority for the pharmaceutical industry given that it is not only associated with a risk of inducing serious side effects, but it can also become a breeding ground for the unauthorized distribution and counterfeiting of medicinal products. Astellas is working to identify the compounds under development that have the potential to be used in doping and to prevent the misuse of those compounds. 

In October 2016, Astellas made a global agreement with the World Anti-Doping Agency (WADA) to partner on the prevention of misuse and abuse of medicinal products for doping in sports which aims to contribute to the eradication of doping and improvement of public health^*5. 

Doping in sports relies primarily on the misuse and abuse of commercially available medicinal products, as well as compounds in development that are not as well-known or easily detected. To support WADA in its efforts to address this issue, Astellas identifies compounds solely developed by Astellas or its affiliates with the potential for sport-related doping abuse and cooperates in sharing relevant information to aid WADA in the organization’s development of detection methods for these compounds. Additionally, Astellas cooperates with WADA to minimize the risk of misuse of compounds with doping potential during clinical trials to avoid opportunities for abuse. 

Astellas places highest priority on ensuring robust manufacture and stable supply of safe and effective pharmaceuticals to patients. To ensure this, we have established our own standards aligned with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) as the basis for consistently achieving high levels of quality. We apply these standards to manufacturing facilities and equipment, and to all stages from raw material procurement and storage to production and shipment.

Astellas is continuously investing in various manufacturing facilities with the aim of maintaining and strengthening stable supply. In 2020, construction of the Center for Active Ingredient for Biopharmaceuticals was completed at Toyama Technology Center. Bio-drug substances for clinical trials and commercial use are manufactured at the Center and supplied according to global standards. In addition, construction of the Third Fermentation Building has commenced. When the construction is completed, the active pharmaceutical ingredients of immunosuppressant Prograf® that suppress rejection after organ transplants will be manufactured at the facility. In Yaizu Technology Center, construction of aseptic drug product manufacturing lines which allow flexibility to manufacture not only antibodies but also new modalities requiring high-level technology in the future was initiated. In the gene therapy domain, Astellas has established plants in South San Francisco, California and Sanford, North Carolina (GMP manufacturing commenced in 2022), building capability for the in-house manufacture and supply of adeno-associated virus (AAV) drug substances, AAV products, and plasmids which provide self-sufficiency from research to the commercialization of gene therapy programs. Meanwhile, in the cell therapy domain, Astellas has established a new manufacturing base in Westborough, Massachusetts, in April 2020, strengthening our capability to manufacture GMP-compliant, cell-based drug substances and products for use in cell therapy. By constructing such in-house, state-of-the-art manufacturing facilities, we aim to build a more robust manufacturing system capable of supplying high quality products going forward.

Astellas has quality systems for auditing both internal sites and external manufacturing and distribution partners. The risk-based auditing approach determines the sites audit frequency and intensity. Internal audits are conducted on all Astellas organizations that conduct current Good Manufacturing Practice (cGMP) and/or current Good Distribution Practice (cGDP) activities at all points across the product lifecycle and across the supply chain, in accordance with documented policies and procedures. Quality audits are conducted for new or established external partners of Astellas. Such audits are performed to evaluate compliance with cGMP, cGDP and applicable Astellas requirements. In fiscal 2022, Astellas performed a total of 444 audits, including 31 internal audits and 413 quality audits of external partners globally.

Supply chains are becoming more complicated than ever due to the increase in global products and diversification of modality, along with the increase in partnerships and cooperation with suppliers. Taking these environmental changes into account, Astellas is strengthening its supply chain management globally by building a framework to centrally manage demand forecasts, inventory data and supply plans for regions all over the world, encompassing the manufacture of drug substances through to finished product supply. 

Moreover, in addition to building a global logistics and distribution network to develop the functions and capabilities which flexibly meet the various needs for products, including cold chains, Astellas is advancing logistics and trade compliance, including for imports and exports, to enhance the stable supply management. 

Furthermore, in the area of commercial supply chain, Astellas has established a function at three locations: Japan, the Netherlands, and the US to continuously develop the supply chain process adapting to the environment changes and strengthened the management framework in global operations. 

One of the most important missions for a pharmaceutical company is to continuously improve BCP (Business Continuity Plan) and maintain and continue a stable supply of pharmaceutical products even when natural disasters occur. The Ministry of Health, Labour and Welfare released Japanese GDP (Good Distribution Practice) Guidelines which require greater strictness with respect to ensuring quality in storage and shipment under GDP. Meanwhile, MLIT (Ministry of Land, Infrastructure, Transport and Tourism), METI (Ministry of Economy, Trade and Industry), and MAFF (Ministry of Agriculture, Forestry and Fisheries) are promoting “White Logistics,” an initiative aimed at addressing working style reform, driver shortages, CO2 reduction among other issues facing logistics. Under this initiative, consignors cooperate with logistics partners to implement activities for improvement and reform, and build sustainable logistics frameworks.

Under the environment changes surrounding logistics, Astellas, Takeda Pharmaceutical Company Limited, Teva Takeda Pharma Ltd., Teva Takeda Yakuhin Ltd. and Nichi-Iko Pharmaceutical Co., Ltd. have co-established a shared storage and joint distribution platform in Hokkaido, Japan. The platform aims to ensure a diverse and stable supply of pharmaceuticals with adequate contingency, even in the event of a large-scale natural disaster, as well as enhancing efficiency and quality management of product distribution. Astellas will continue initiatives that advance the sharing and standardization of the pharmaceutical logistics within the industry.

The joint distribution platform in Hokkaido has reduced costs. It has not only enabled us to set up a new logistics base but also has reduced the environmental burden through the reduction of carbon emissions. In recognition of these points, Astellas received the Minister of Economy, Trade and Industry Award in 2018 for the Green Logistics Excellent Business Award.

From 2021 onward, a joint distribution center was added in Kyushu, and a system for product inventory and supply management was established at four locations in Japan. 

A stable supply of medicines is necessary for patients to have continuous access to Astellas products. The stable supply requires minimizing the risk of accidents caused by manufacturing. Some drug substances, which are active pharmaceutical ingredients, are synthesized through multiple chemical reactions. As a result, chemical reactions and associated raw materials have many inherent risks that can cause such as fires.

In order to minimize these risks during the manufacturing process, Astellas conducts assessments at the R&D stage of manufacturing for each drug substance whether there are any risks of accidents such as unusual reactions and fires caused by uncontrolled chemical reactions and static electricity discharge. For example, we understand the decomposition starting temperature of all chemical substances used in the manufacturing and the calorie generated by chemical reactions. In addition, we design proper manufacturing equipment that prevents fires. In these ways, we continuously improve our manufacturing processes to make them safer and finalize the processes to deliver VALUE to patients.

This practice is important to ensure that patients have continuous access to Astellas products and treatments through our efforts to create a stable supply via responsible manufacturing practices. 

We have introduced universal design to certain product packaging. For example, the universal design packaging of Bonoteo® 50 mg tablets, which is administered once every 4 weeks, features packaging with good openability. To prevent patients from forgetting to take the drug, there is an area provided on the packaging to write the day when the drug should be taken. A small sticker to be used on a calendar is also attached. In addition, the packaging uses a universal design font type for easy reading. 

Astellas has established its own quality standards in compliance with current Good Manufacturing Practice (cGMP) and applies these standards to Astellas Group manufacturing sites.

Astellas has set forth the quality assurance function and activities in the Quality Manual. The Quality Manual sits on the apex of the document management system hierarchy. Underneath the Quality Manual, policies, standard operating procedures, and guidelines exist defining quality assurance systems, operational management and procedures for a variety of quality assurance-related activities at the global, regional and national levels. Education and training programs are implemented to promote understanding and awareness of these matters.

These documents are revised periodically and as necessary. We respond swiftly to developments in the external environment, such as regulatory changes and amendments through an established Regulatory Intelligence system.

Astellas has developed a robust global quality assurance system so that it can ensure patients worldwide a supply of uniformly high quality of pharmaceuticals. This quality management system was developed to be consistent with our quality policy on a global, company-wide basis. The organizational structure of the global quality assurance system incorporates the quality assurance activities of all Astellas affiliates. Our sales affiliates globally receive ongoing support in strengthening our quality culture whilst educating our personnel to the highest standards.

Astellas is developing environmentally-friendly pharmaceutical manufacturing processes not only for patients, but also for a sustainable society coexisting with communities and nature. The chemical synthesis of drug substances, which are active pharmaceutical ingredients, generally involves the use of environmentally hazardous substances, like organic solvents. Astellas is evaluating the environmental effect of drug-manufacturing processes and taking necessary measures in order to minimize impact.

Recently, Astellas started collaborating globally with subcontractors at the early-stage development of manufacturing processes. In addition, we have also started working on several activities together with our subcontractors to evaluate and reduce environmental impact. These include: sharing our environmental standards, understanding their Environment, Health & Safety policies and manufacturing processes in detail, examining the treatment of environmentally hazardous gas and waste liquids generated during chemical synthesis, planning countermeasures for potential environmental impact. Through these collaborative activities, we are developing manufacturing processes with low-environmental impact.

Astellas strives not only to ensure the quality and stable supply of pharmaceuticals, but also to pursue environmentally-friendly manufacturing of pharmaceuticals all over the world. Through these measures, we contribute to the benefit of patients and environmental preservation on a global scale. 

To promote sustainable pharmaceutical manufacturing, Astellas arranges opportunities for dialogue with local residents and communities near its manufacturing sites. By proactively disclosing its initiatives, Astellas is working to build good relationships with them.

On the premises of the Kerry Plant in Ireland, our nature reserve is a resource made available to the local community and visitors by creating public walkways and information boards, provided by Astellas, detailing the flora and fauna and biodiversity in the nature reserve.

Astellas holds an annual calendar art competition with local schools on the topics of safety, environment and energy. Funds raised from the sale of these calendars are donated to a local charity. Each year, over 1,000 entries are received from 12 local schools.

Astellas helps in promotion of STEM (Science, Technology, Engineering and Math) to local schools through science and engineering talks and tours onsite and online. Astellas communicates with the local community with the publication of the quarterly Astellas Biodiversity Newsletter. This newsletter contains biodiversity information relative to the season it is published in. Astellas nurtures good community relationships through integration with and the support of many other local interest groups such as a local nursing home, local Men’s Shed Association, Tidy Towns committee, National Park Education Centre, local bee keepers and local bird and bat conservation groups.

One of industry’s biggest challenges is to develop manufacturing processes that do not unnecessarily burden the environment and to develop sustainably within the local community. The efforts made by Astellas to meet the highest manufacturing standards for our life saving drugs, but also the requirement to do so sustainably limiting our impact on the environment have not gone unrecognized. Since April 2020, the Kerry plant has won SEAI^*3 award under the category of Energy Team of the Year. 

Astellas’ Medical Representatives (MRs) provide information on appropriate usage based on on-label information to healthcare professionals to ensure that Astellas pharmaceutical products are used safely and effectively. In promotion of Astellas products, MRs act with high ethical standards and strictly comply with applicable laws and regulations, industry codes and company policies including the Astellas Group Code of Conduct.

Medical Science Liaisons (MSLs) engage with healthcare professionals to exchange scientifically based information to advance their understanding and the safe and effective use of our products in patient care. MSLs also act with high ethical standards and provide reliable, clear, fair, balanced and unbiased medical and scientific information. MSLs refrain from promotion of products, and observe high ethical standards, making compliance their top priority. 

Astellas has a responsibility to provide truthful, balanced and unbiased medical information in response to inquiries regarding our products. By fulfilling this responsibility, Astellas supports the safe and effective use of our products.

In countries throughout the globe, we have Medical Information Call Centers that respond to a variety of inquiries. In our larger call centers, we have systems that allow for 24-hour responses to urgent inquiries, even on business holidays.

Astellas makes continuous efforts to improve its medical information services, with the aim of providing accurate, appropriate and consistent information. As part of these efforts, a global medical information system is used to receive inquiries for information and document medical responses from group companies around the world. This allows us to respond to inquiries in a simple, swift and accurate manner. At the same time, we can analyze feedback from patients and medical professionals and communicate these insights to support the life cycle management of our products.

We have recently implemented new regional medical information web portals for HCPs to allow for additional and direct access to information regarding our products.

Astellas has a recall system in place that is activated when the safety, efficacy or quality of a product is brought into question. The system ensures relevant information is promptly passed on to medical institutions and other affected parties and that a recall of the product in question is instigated.