Immuno-cells of patients can not be sterilized by heat or filtration, as sterilization of heat or filtration will also kill immuno-cells as well as bacteria. Therefore, it is necessary to avoid contamination of bacteria from air or immuno-cells of other patients in cell-processing as a safety control.
There are two main elements of safety controls as stated below;-

(1) Facility and Equipments
Since immuno-cells of patients must be prevented from air contamination, the place, where immuno-cells are processed, must be closed facility. MEDINET controls cleanness of air within the CPC by followings;-

The CPC is also facilitated with clean benches where cell-processing is conducted at class 100 of air cleanness.(See further information at “Introduction to Cell Processing Center.”)

(2) Safety Inspection
MEDINET forms a series of safety inspections into the Standard Operating Procedure (“SOP.”) Inspection Engineers will perform safety inspections from pre-processed immuno-cells to post-processed immuno-cells. These safety inspections include sterile test, test using a small amount of autologous plasma and other tests.

In general, quality assurance of a product is performed over production and resources. MEDINET has established its original quality assurance management, which is based on concepts of Good Manufacturing Practice (“GMP”) and Bio Safety, over materials, inspections, and cell-processing. Our quality assurance management is mainly structured with three factors;-

(1) Materials
MEDINET select pharmaceuticals, medical devices or equivalent materials (e.g.; media, culture bags/flask and etc.) as materials used in cell-processing. The selection of materials is one of key factor to ensure quality and safety of processed immuno-cells.
The criteria of selected materials used in cell-processing are followed;-

(2) Quality Inspection
Quality inspection in cell-processing is that cell engineers generally inspect sterility and function of immuno-cells. To ensure fair evaluation of quality, MEDINET assigns inspection engineers at separated division from cell-processing division. This is only because quality inspection must be performed with view of objective evaluation of quality. Quality inspection is performed at each stage of cell-processing, and includes visual observation, sterile test, cell number test, viability test, endotoxin test, and etc.

(3) Evaluation of Performance
The key factor for quality assurance management is to perform PDCA (Plan-Do-Check-Act) cycle over cell-processing. PDCA cycle refers establishment of the SOP for cell process and inspection, implementation of the SOP, evaluation of processed immuno-cells, and improvement of performance in our quality assurance management.

MEDINET has implemented such PDCA approach to ensure quality and safety of processed immuno-cells, and has also taken third party evaluation, such as ISO9001, on our quality assurance management. (See further information at “ISO9001 Qualified Service.”)

In cell therapy, quality of processed cells is generally depending on who perform cell-processing. In other word, cell-processing is manual-handing process, so that experience and skills of cell engineers directly influence quality of processed cells. To keep quality of processed cells, cell engineers must be trained, and will be able to perform appropriate process by cell condition.
MEDINET has established original training programs for cell engineer and inspection engineer, and has set certain criteria in the training program for our cell engineers and inspection engineers to learn at each stage. Cell engineers and inspection engineers, who are qualified as professionals in cell-processing and quality inspection through such training program, are allowed to engage in actual cell-processing and quality inspection under the supervision of physicians at Contracted Medical Institution.

MEDINET provides a computerized central system, which controls temperature, carbon dioxide concentration, and oxygen concentration for storing media and drugs in real time for 24 hours and 365 days. Such computerized central system will also send an e-mail notification to mobile phones of cell engineers when accident happens in clean rooms.

MEDINET makes day-to-day efforts to ensure safety and quality of processed-cells so that the Contracted Medical Institutions can safely conduct immuno-cell therapy.