1. Launch of Traceability Service Platform across the Value Chain for Cell and Gene Therapy Products to Ensure the Safety and Security of Regenerative Medicine
Cell and gene therapy products in regenerative medicine, in which cells harvested from patients or donors are cultured, processed, and dosed to patients, are subject to product selection errors, temperature deviations during transportation, and scheduling issues such as changes due to patient conditions or culture time. Therefore, quality assurance based on strict individual identification and process tracking of each cell and gene therapy product throughout the value chain is necessary to achieve reliable information sharing among stakeholders.
To solve these issues, Hitachi launched the “Hitachi Value Chain Traceability Service for Regenerative Medicine” as a service platform for integrated management of the value chain of cell and gene therapy products, and started offering it in April 2021. This service platform will enable integrated management of traceability information across the entire value chain, which can be shared by all relevant stakeholders.
In the future, Hitachi will provide this service to the medical and pharmaceutical industries as one of the Lumada solutions for accelerating digital innovation, and will also expand the service to the specialty drug industry and overseas.
Hitachi will continue to contribute to the spread and development of regenerative medicine, with the aim of making this service platform the industry standard.
[01]Overview of Hitachi Value Chain Traceability Service for Regenerative Medicine