At Chugai, we use biotechnology to develop high-quality and innovative pharmaceuticals that meet medical needs, and we are also convinced that there is a need for further innovation. Biotechnology has the potential to replace traditional chemical methods, and it will allow us to manufacture pharmaceuticals, including therapeutic and diagnostic agents, in a more sustainable and eco-friendly way. Many of our most mainstay products are already being produced using biotechnology, and Chugai is actively seeking to expand its use. We will continue to work with our internal and external partners to conduct further biotechnology-based pharmaceutical research and development. Chugai will take every necessary action to address all safety, health, and environmental concerns around the use of biotechnology in pharmaceutical manufacturing and R&D, and we will be transparent with the public about our practices.

In the development of pharmaceuticals, biotechnological research increasingly makes use of microorganisms and cells that can cause disease. Chugai’s research is strictly compliant with the globally recognized biosafety standards. Therefore, we only use microorganisms and cells with limited pathogenicity to humans or animals or which have been modified to survive only in laboratory environments which are tightly regulated by government agencies to avoid leaks into the outside world. Chugai also discards these biological materials after inactivation in facilities of that meet appropriate standards to prevent environmental contamination. These measures have been shown to work in preventing adverse environmental effects. At Chugai, we diligently assess risks based on the precautionary principle, and we take every measure to minimize such risks in accordance with all applicable regulations.

One form of biotechnology involves genome editing. This can be used to modify targeted genes in many species and it has led to innovations in many fields, including healthcare, agriculture and manufacturing. Chugai believes that basic and preclinical research using genome editing technologies with 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 only use genome editing technologies for scientific and ethical purposes. Chugai also agrees with the clinical application of genome editing technology. However, genome editing technologies are currently being researched so that it can be applied to 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 is not considering the use of genome editing technology for human germline cells, but only for the clinical use of human somatic cells. We will consult with academic institutions and relevant authorities and we will carefully consider ethical issues.

In addition to commonly used microorganisms and cells, genetically modified organisms are increasingly being used in the production of biotechnology-based formulations of peptide or protein drugs. Since employees may come in contact with these biological materials during their work, they must be carefully protected from contamination. In safeguarding the health of our employees, we must make every effort to avoid adverse effects or detect them early if they do occur. The results of regular employee health checks by health care physicians are used to ensure the effectiveness of precautions taken during work. In addition, Chugai complies with global guidelines for protecting the health of employees who are involved in biotechnological research, namely the World Health Organization’s (WHO) Laboratory Biosafety Guideline^*1 for handling and transporting biotechnology-based organisms in research facilities, and the Cartagena Protocol’s regulations^*2 for the safe handling and transport of genetically modified organisms.

Chugai recognizes that waste containing pathogenic microorganisms, cells, or genetically modified organisms used in the research and development of biotechnology-based drugs is a potential source of environmental pollution. We believe that such substances need to be inactivated to avoid adversely affecting human health and to prevent them from diffusing into the environment alive. The above-mentioned laboratory biosafety guidelines and the Cartagena Protocol stipulate safe handling methods for microorganisms, cells, or genetically modified organisms involved in biotechnology. By complying with these guidelines and protocol, Chugai will handle genetically modified organisms and conduct biotechnology research in ways that do not affect the environment.

Protection of biodiversity is one of the most important issues that must be addressed for posterity with the rapid global rise of biotechnology. Chugai strongly agrees with the principles stipulated by the Convention on Biological Diversity^*3 and Nagoya Protocol^*4 on the preservation of biodiversity and proper use of genetic resources.

*1. World Health Organization. Laboratory biosafety manual, 4th edition: Biosafety programme management
https://www.who.int/publications/i/item/9789240011434

*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/