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. 

At Astellas, ensuring patients have continuous access to safe and effective medicines is a top priority. To deliver on this commitment, we maintain rigorous standards aligned with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP), supported by comprehensive quality management across the entire value chain—from sourcing raw materials to manufacturing, storage, and distribution. Through a global manufacturing network that spans Japan, Ireland, the United States, China, and other regions, and in collaboration with manufacturing partners, we have built a resilient global supply network that helps ensure a reliable supply of medicines to patients worldwide.
 

To support a broad range of modalities, we continue to expand our manufacturing capabilities. In addition to small-molecule medicines, we have established in-house capabilities across biologics (e.g. antibodies), gene therapies, and cell therapies, while making ongoing investments to ensure future product supply. Through our technology centers, which support both clinical and commercial manufacturing, we have built an integrated framework that enables a seamless and accelerated path from development to commercialization. For more information, please visit here.

Astellas places strong emphasis on embedding quality as part of its organizational culture, rather than treating it solely as a compliance requirement. Through leadership commitment to quality, a patient centered mindset among employees, and mechanisms for continuous improvement, the company works to foster a strong Quality Culture. It also promotes business improvement activities using methods such as Lean Six Sigma, seeking to enhance quality while improving manufacturing process efficiency.

The functions and activities of the quality assurance organization are defined in the Quality Manual. Based on this manual, organizations in each country and region establish guidelines and standard operating procedures for quality assurance systems and related operations at the global, regional, and country levels. They also promote understanding and implementation through education and training programs. These documents are reviewed regularly and as needed so that Astellas can respond promptly to changes in the external environment, including new or revised regulations.

To ensure the reliable supply of consistently high quality medicines to patients worldwide, Astellas has built a robust global quality assurance system. Quality assurance activities at all Astellas sales affiliates are incorporated into the global quality management system, while the company continues to strengthen a quality-focused corporate culture and develop talent to the highest standards. A regulatory intelligence framework is also in place to support timely responses to regulatory changes in each country.

The Quality Manual defines Astellas’ global Quality Management System (QMS) and sits at the top of the document hierarchy. It establishes the quality policy, organizational framework, and core processes to ensure regulatory compliance, product quality, and continuous improvement.

Supporting documents such as policies, SOPs, and guidelines provide detailed requirements for key QMS elements, including risk management, change control, audits, CAPA, and product/process controls across global, regional, and local levels. The QMS is maintained through a risk-based approach, including change management, root cause analysis, audits, and management review, supported by training programs to ensure personnel competence.

Documents are periodically updated, and regulatory changes are addressed through a Regulatory Intelligence system to ensure ongoing compliance.

Astellas operates a globally harmonized QMS to ensure consistent product quality worldwide. The system integrates all affiliates under a unified framework aligned with global standards. Affiliates are supported through training, quality culture initiatives, and implementation of risk based QMS processes, including CAPA and audits, to continuously improve quality performance.

Astellas regularly audits the quality assurance systems of both internal Group sites and external manufacturing and distribution partners. The frequency and depth of these audits are determined based on risk analysis. Audits of internal sites cover all organizations that apply current Good Manufacturing Practice (cGMP) or current Good Distribution Practice (cGDP). They are conducted across all stages of the product lifecycle and throughout the supply chain in accordance with established policies and procedures.

For external partners, audits assess compliance with cGMP, cGDP, and Astellas requirements, regardless of whether the partner is new or existing. As modalities diversify and the number of manufacturing partners increases, the audit scope continues to expand. Astellas maintains an effective and efficient audit framework through a risk-based approach.

Supply chains are facing increasingly complex and diverse risks, including heightened geopolitical uncertainty, pandemics, and more frequent natural disasters. Astellas is strategically strengthening resilience across its entire supply chain.

By considering geopolitical developments, product lifecycles and technical requirements, we proactively mitigate potential supply risks. For key strategic products, we implement double-sourcing strategies where appropriate by securing multiple production sites. The company is building a supply structure designed to help prevent interruptions in product supply to patients, even if geopolitical risks materialize.

In response to evolving business needs including the growth of global products, increasing modality diversity, and expanded collaboration with partners and suppliers, Astellas is strengthening end-to-end global supply chain management, from drug substance manufacturing through product delivery. This includes implementing integrated systems that provide centralized visibility of demand forecasts, inventory levels, and supply plans across regions.

To support a diverse and growing portfolio, Astellas has established a global logistics network capable of meeting a wide range of product requirements, including temperature controlled and cold-chain products. The company also maintains a strong focus on logistics compliance, including import and export regulations, while continuously enhancing supply reliability and operational resilience. Through a globally integrated management framework for commercial supply chain operations, Astellas continues to evolve its processes and capabilities in response to changing market dynamics and external conditions.

Maintaining a reliable supply of medicines during emergencies, including natural disasters, pandemics, and other unforeseen disruptions, is a critical responsibility for Astellas. To enhance resilience and business continuity, we have established a multi-layered business continuity planning (BCP) framework across products, modalities and geographies. By diversifying manufacturing capacity, strategically positioning inventory, and securing alternative logistic routes, Astellas strengthens its ability to respond to disruption and help ensure uninterrupted access to medicines for patients worldwide.

Through innovation in formulation technology and device design, Astellas pursues administration that is simpler, safer, and more convenient. For example, for the ophthalmology product IZERVAY®, the company is developing a prefilled syringe to reduce the burden for preparation by healthcare professionals and improve accuracy during administration. We are also advancing innovative technologies in cell therapy to expand patient access and make these treatments available to more patients around the world.

Astellas is committed to a patient-centered approach to product design, aiming to enhance medication safety, usability and accessibility. To help prevent medication errors, product names are printed directly on capsules and tablets, while drug names and strengths are designed to remain clearly identifiable even after PTP blister packs are separated. The company also improves label readability through the usage of highly visible colors, layouts, and fonts. To support better patient experiences, Astellas continuously seeks to reduce the burden of medication use through optimized dosage forms and smaller formulations. In addition, selected products incorporate universal design features, including easy open packaging and universal design fonts, helping to ensure that medicines are accessible and easy to use for patients with diverse needs.

Astellas has set greenhouse gas (GHG) reduction targets aligned with the 1.5°C goal of the Paris Agreement. For Scope 1 “Direct emissions” and Scope 2 “Indirect emissions,” the company aims to reduce emissions by 63% by fiscal 2030, using fiscal 2015 as the baseline year. Astellas has also set a long-term goal of achieving net-zero emissions across the entire value chain by 2050.

For Scope 3 “Emissions across the supply chain,” Astellas has set a reduction target of 37.5% by fiscal 2030 and is working with suppliers to reduce emissions. The company is systematically introducing renewable energy at manufacturing sites, including installing solar power systems and switching purchased electricity to renewable sources, thereby reducing its carbon footprint.

Astellas is committed to minimizing environmental impact of its pharmaceutical manufacturing operations. The company optimizes the use of substances with environmental impact, such as organic solvents, evaluates the environmental impact of manufacturing methods, and implements the measures needed to reduce environmental burden as much as possible.

Astellas also collaborates with contract manufacturers from the manufacturing process development stage to assess environmental impact and reduce environmental burden. Specific activities include sharing Astellas environmental standards, understanding the environmental, health and safety policies and manufacturing processes of contract manufacturers, confirming and reviewing wastewater treatment methods, and developing countermeasures based on these assessments.

Astellas also considers the impact of pharmaceutical manufacturing activities on biodiversity and works to minimize the impact on ecosystems at manufacturing sites. To promote circular resource use, the company introduces biomass plastics for packaging materials used in manufacturing processes, promotes waste reduction and recycling, uses water resources efficiently, and manages wastewater thoroughly. Astellas also maintains and strengthens appropriate chemical management systems in line with global regulatory trends.

The rapid advancement of digital technologies is transforming pharmaceutical manufacturing and quality management. Astellas actively leverages artificial intelligence (AI), automation technologies, and data science to optimize manufacturing processes, enhance quality management, and improve operational efficiency.

Astellas is strengthening knowledge management at manufacturing sites. The company is building next generation manufacturing operation models by introducing work support tools using generative AI and data mining technologies and by using digital twin technologies to simulate and optimize manufacturing processes and supply chains. By leveraging these digital technologies, Astellas aims to transform individual expertise into organizational knowledge and enable faster, higher-quality product supply.

In addition, we established Cellafa BioScience Inc., a joint venture with YASKAWA Electric Corporation, to develop a cell therapy manufacturing platform that leverages advanced robotics and AI technologies. By combining robotics-driven automation with AI enabled process development, the platform is designed to deliver high levels of reproducibility and precision while accelerating the development of robust and reliable manufacturing processes. The technologies employed have received Advanced Manufacturing Technologies designation from the U.S. Food and Drug Administration (FDA).

Astellas continues to enhance its pharmacovigilance (PV) system by strengthening collaboration among the PV function, other related departments, sales affiliates, and licensing partners. These efforts support not only compliance with regulatory requirements, but also the expansion of product strategies, the provision of reliable product information, and the promotion of appropriate product use.

Astellas has established systems to collect product safety information broadly. Annual PV training is provided not only to employees closely involved in PV, but also to all employees and contractors, including those at sales affiliates, to maintain and strengthen the ability to collect safety information appropriately and promptly. In addition, when non-PV departments outsource work to external vendors, requirements for collecting safety information are added to outsourcing agreements as needed.

By strengthening collaboration between the PV function and other departments, Astellas also uses real-world data, such as large-scale medical databases, to evaluate product safety and minimize risks. The company continues to explore and assess AI and automation technologies that can support safety information monitoring, database intake, processing and reporting, and the early detection and analysis of safety signals, thereby further advancing its safety information management system.

Astellas has established its own quality standards in compliance with current Good Manufacturing Practice (cGMP) and applies these standards at each manufacturing site. The table in the Japanese section summarizes the history of inspections by the U.S. Food and Drug Administration (FDA), including the number of inspections, warning letters issued, Form 483 observations, and the sites that received Form 483s.

Form 483 is issued when FDA inspection findings identify observations that may indicate potential violations of the Federal Food, Drug, and Cosmetic Act or related regulations. The Norman facility in the United States was transferred to Avara Norman Pharmaceutical Services, Inc. in August 2016.

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 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 established a recall system to be used when issues arise related to product safety, efficacy, or quality. The company promptly communicates relevant information to medical institutions and affected stakeholders and conducts recalls of the applicable products. The table in the Japanese section summarizes the annual number of recalls by severity classification, including Class I, Class II, Class III, and unclassified recalls. An asterisk indicates an authority-led recall.