GMP-compliant cell culture facility

We are equipped with a GMP-compliant cell culture facility

Cancer immunotherapy requires the processing, cultivation, and preparation of immune cells—collectively referred to as "cell processing." Each of these steps demands a high level of safety and quality control, comparable to pharmaceutical manufacturing. These standards are referred to as GMP (Good Manufacturing Practice).

JSRM Advanced Cell Processing Operator (J-ACPO) on staff

JSRM Advanced Cell Processing Operator (J-ACPO) is a qualification certified by the Japanese Society for Regenerative Medicine. It refers to cell culture technicians who have a theoretical understanding of the basics and applications of cell culture in regenerative medicine and are capable of providing guidance in this field. This qualification is an important one for ensuring the quality of cell culture, and you can use it with confidence.

GMP Explained in Simple Terms

A facility with properly managed equipment and environment that can prevent human errors
A hygienic facility that prevents immune cell contamination or quality degradation
A facility designed to consistently maintain high quality

* In Europe and the United States, cell processing that complies with GMP grade is mandatory. Similarly, Japan has also established GMP standards for pharmaceuticals. Currently, acquiring manufacturing licenses for pharmaceuticals requires that the production facility meets GMP standards.

In response to these conditions, our clinic has established a GMP-compliant Cell Processing Center (CPC), where skilled technicians carry out the cultivation, processing, and preparation of immune cells to ensure safety and maintain high quality.

Introduction to GMP-Compliant Cultivation Facilities

Clean Room

Depending on the purpose of the operation, clean rooms and semi-clean rooms with appropriate equipment and space are provided. When aseptic processing is required, the work is carried out in clearly separated rooms to prevent contamination by microorganisms.

Equipment

• Pass boxes are installed for transferring materials, and human movement is conducted along a one-way path to prevent backtracking during operations.
• The ceilings, walls, and floors are designed to minimize dust accumulation. To prevent mold growth and the backflow of outside air, drains are not installed in clean rooms or certain other rooms. Water used during operations is completely removed from the room without leaving any behind.
• Temperature and humidity are strictly controlled, and clean air—processed through specialized filters—is supplied to both clean rooms and semi-clean rooms to prevent bacterial contamination.

Management

To ensure personal information protection, entry and exit to clean rooms and semi-clean rooms is strictly controlled under a centralized management system. This includes an integrated information system and multiple layers of security locks.
In addition, all operational records and surveillance camera footage are centrally monitored and managed.