Biotechnology Policy

At Chugai, we use biotechnology to develop high-quality and innovative pharmaceuticals that meet medical needs, and we also recognize the need for further innovation. Biotechnology has the potential to complement traditional chemical methods, and it will allow us to manufacture pharmaceuticals, including therapeutic and diagnostic agents, in a more sustainable and environmentally friendly way. Many of our core products are already manufactured using biotechnological processes, and Chugai is actively working to expand the use of biotechnology. We will continue to work with our internal and external partners to conduct further biotechnology-based pharmaceutical research and development. Chugai will take necessary measures to address safety, health, and environmental concerns associated with the use of biotechnology in pharmaceutical manufacturing and R&D, and will strive to ensure transparency regarding its activities.

In pharmaceutical development, biotechnology research may involve handling biological materials such as microorganisms, cells, and genetically modified organisms. Chugai’s research strictly complies with globally recognized biosafety standards. Therefore, we use only biological materials that are appropriately managed in accordance with applicable laws and internal standards. Chugai also disposes of these biological materials only after appropriate inactivation (sterilization) in facilities that meet required standards to prevent environmental contamination. Through these measures, Chugai strives to reduce environmental impact. At Chugai, we carefully assess risks based on the precautionary principle, and we take measures to minimize such risks in accordance with all applicable regulations.

Genome editing is one form of biotechnology. It can be used to modify targeted genes in many species and has led to innovations in many fields, including healthcare, agriculture and manufacturing. Chugai believes that basic and preclinical research involving genome editing in mammalian cells must be conducted according to strict legal and ethical rules and with responsible oversight to ensure the health and well-being of patients. In compliance with applicable laws and guidance, Chugai will use genome editing technologies only for scientifically valid and ethically justified purposes. Chugai also monitors developments toward the clinical application of genome editing technology. However, genome editing technologies are currently under investigation for potential use in clinical trials. Regarding regulations on the clinical application of genome editing, Chugai believes that governments and expert committees in each country will discuss safety issues in the future. Chugai will also consult with academic institutions and relevant authorities, and carefully consider ethical issues while respecting international consensus.

In addition to commonly used microorganisms and cells, genetically modified organisms are increasingly being used in the production of biotechnology-based peptide and protein drugs. Since employees may come into contact with these biological materials during their work, they must be carefully protected from exposure. In safeguarding the health of our employees, Chugai is committed to minimizing risks and ensuring early detection should any adverse effects occur. We provide annual regular health check-ups in accordance with the Industrial Safety and Health Act, as well as health management tailored to employees’ job responsibilities. These results are reviewed by our occupational physicians and are used to ensure the effectiveness of precautions taken during work. In addition, Chugai complies with the World Health Organization’s (WHO) Laboratory Biosafety Manual^*1.

Chugai recognizes that waste containing pathogenic microorganisms and genetically modified organisms used in the research and development of biotechnology-based drugs may, if not properly managed, become a factor that could affect the environment. We believe that such substances should be disposed of after inactivation to avoid adversely affecting human health and to prevent their release into the environment.

The Laboratory Biosafety Manual and the Cartagena Protocol^*2 provide fundamental principles and an international framework for the safe handling of microorganisms, cells, and genetically modified organisms involved in biotechnology. By complying with these guidelines and the protocol, Chugai will handle genetically modified organisms and conduct biotechnology research with due consideration for the environment.

With the rapid global expansion of biotechnology, protecting biodiversity is one of the important issues facing future generations. Chugai supports the principles set out in the Convention on Biological Diversity^*3 and the Nagoya Protocol^*4 regarding the conservation of biological diversity and the fair and equitable sharing of the benefits arising from the utilization of genetic resources.

*1. World Health Organization. Laboratory Biosafety Manual, 4th edition
https://www.who.int/publications/i/item/9789240011311

*2. Convention on Biological Diversity. Text of the Cartagena Protocol on Biosafety
https://bch.cbd.int/protocol/text/

*3. Convention on Biological Diversity. Text of the Convention
https://www.cbd.int/convention/text/

*4. Convention on Biological Diversity. Text of the Nagoya Protocol
https://www.cbd.int/abs/text/