Biotechnology Policies

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 strictly complies with globally recognized biosafety standards. Therefore, we only use microorganisms and cells genetically transfected using highly safe viruses or which have been modified to survive only in laboratory environments which are tightly regulated by laws and regulations to avoid leaks into the general environment. Chugai also discards these biological materials after inactivation (sterilization) in facilities 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 supports the potential clinical application of genome editing technology. However, genome editing technologies are currently being researched for potential application 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. We will consult with academic institutions and relevant authorities, and 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. We have a regular checkup and an additional special medical checkup according to employees’ jobs every year. Our company doctors check these results, which are used to ensure the effectiveness of precautions taken during work. In addition, Chugai complies with global guidelines for protecting the health of employees involved in biotechnological research. These include 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 for the safe handling and transport of genetically modified organisms.

Chugai recognizes that waste containing pathogenic microorganisms and 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 their release into the environment.

The laboratory biosafety guidelines and the Cartagena Protocol^*2 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 agrees with the principles stipulated by the Convention on Biological Diversity^*3 and Nagoya Protocol^*4 on the conservation of biological diversity and the fair and equitable sharing of the benefits arising out of 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/