Safety and Quality Control

MEDINET processes tissues and cells that are used for medical treatment, and we believe that our most important task is to provide safe and high-quality technologies and services to patients and healthcare providers so that they can use those tissues and cells with peace of mind.

MEDINET has prioritized this task since it first started supporting cell processing for medical treatment used in immuno-cell therapy in 1999. To provide safe and high-quality regenerative medicine and cell therapy, we have accumulated extensive expertise, established detailed quality assurance systems, including a manufacturing quality control system for safely conducting cell processing, cell processing facilities (CPFs) optimized for regenerative medicine and cell therapy, and a transport management system.

Regenerative medicine and cell therapy involves processing patients’ own cells and tissues at CPFs and using them to restore and regenerate lost tissues and organs. Our CPFs abide by laws concerning regenerative medicine and cell therapy (The Act on the Safety of Regenerative Medicine and The Act on Pharmaceuticals and Medical Devices [PMD Act]). We have also established a strong safety control system using our expertise accumulated over 16 years.

  • 1 Facilities

    CPFs that comply with laws concerning regenerative medicine and cell therapy. Equipment and devices that affect cell quality are under a 24-hour surveillance using an online monitoring device.

  • 2 Management of processed cells

    Processed cells are managed using bar code and other systems.

  • 3 Engineers

    Engineers are required to receive technical training regarding cell processing, and continuous education for specialized knowledge and ethics.

  • 4 Materials and ingredients

    The first criterion for choosing materials and ingredients is pharmaceuticals. We confirm whether they comply with the Japanese Standards For Biological Ingredients. We select materials and ingredients after confirming whether they are traceable back to their manufacturers.

  • 5 Transport

    Following the World Health Organization’s “Guidance on Regulations for the Transport of Infectious Substances,” we use packages optimized for the transport of processed cells. We conduct transport management, which takes into consideration factors such as poor weather.