Infection and Safety Risks Associated with Human- and Animal-Derived Raw Materials
First written in FY2016. 1 of 4 entries say "Worsened", first in FY2018. Latest entry: FY2024.
0 other companies' latest entry also says "Dropped".
- FY2024DroppedAnnual reportIn the FY2024 business risk section, infection and unknown-virus risks associated with human cell tissue and animal-derived materials cannot be confirmed as a separate item.
- FY2020RestatedAnnual report
「In regenerative medicine products using human cell tissue, characteristics of the human cell tissue vary, creating the possibility that products may fail to meet specifications and cannot be shipped. In addition, animal-derived materials are used in the raw materials and culture media used in the manufacturing process, and the possibility that harm from unknown viruses or other effects could occur and affect the company's business performance cannot be completely ruled out.」
The company continues to disclose the risks of failure to meet specifications due to variability in human cell tissue and harm from unknown viruses associated with animal-derived materials. - FY2018WorsenedAnnual report
「In regenerative medicine products using human cell tissue, characteristics of the human cell tissue vary, creating the possibility that products may fail to meet specifications and cannot be shipped. In addition, animal-derived materials are used in the raw materials and culture media used in the manufacturing process, and the possibility of harm from unknown viruses or other effects cannot be completely ruled out.」
In addition to the existing risks of infection and unknown viruses, the disclosure explicitly identifies the possibility that variability in human cell tissue could result in failure to meet product specifications and an inability to ship products. - FY2016First statedAnnual report
「Regenerative medicine products using human cell tissue are considered to carry high safety risks because the risk of infection originating from the cell tissue cannot be completely eliminated. In addition, animal-derived materials are used in the raw materials for the company's regenerative medicine products and in the culture media used in their manufacturing processes. The possibility that the use of these animal-derived materials could cause harm from unknown viruses or other effects cannot be ruled out.」
The company identifies infection and harm from unknown viruses originating from human cell tissue and animal-derived materials as potential risks.