Facility Design Policy

Facility Design Policy Overview

Designed a GCTP-compliant cell processing center (CPC)

The basic principle of GCTP is to build a system that minimizes human errors, prevents contamination and quality deterioration and ensures high product quality.
With these basics in mind, our design policy is to pursue always a higher level of quality and safety, develop ourselves necessary technologies and incorporate them in order to manufacture cell/tissue-derived investigational new drugs in a safe and stable manner.

Facility Design Policy Details

The 5 axes of the CPC facility design

Cell/tissue-based drugs cannot be sterilized. Therefore, any impurities or possible causes of microbial contamination should be eliminated from the entire manufacturing process. Furthermore, the manufacturing process should be free of errors such as use of a wrong raw material and deviations that affect the product quality, in order to maintain a consistent level of quality. Important factors to realize these are the CPC hard design, whereby cleanliness, (such as the number of suspended particulates), room pressure and traffic lines of people and materials are strictly controlled, and the CPC soft design incorporating hygiene management, process management, environmental monitoring and backup systems.

At PharmaBio, we have realized the CPC design that takes all the important points into consideration, based on our past experience.

1. Remove Contamination Risks

Maintenance of cleanliness using HEPA filters and room pressure control

In areas where raw materials are exposed to the air, the areas should be assured of sterile environment. Therefore, in the Cell Processing Center (CPC), cleanliness is maintained with HEPA-filtered clean air and controlled air pressure, and cleanliness is checked by monitoring the quantity of suspended particulates and microorganisms.

Development of decontamination equipment enabling strict changeover

In addition, contamination by non-visible aerosols must be kept in mind for manufacturing processes that handle liquids. This was why we thought that a decontamination system for strict changeovers was required in addition to cleaning after an operation. So we have developed the world’s first in-room decontamination validation equipment Fogact. We have incorporated Fogact into post-operation decontamination of safety cabinets and CO2 incubators.

2. Realize a Complete Decontamination

Regular cleaning and cleaning validation

CPC’s cleanliness is maintained through hygiene control including regular cleaning, in addition to features of the building and facilities such as air-conditioning and maintenance of pressure differential. In routine cleaning, chemicals selected appropriately for each room are used to wipe work surfaces, machine surfaces, walls, floors, etc. in a defined manner and cleaning validation is conducted through bacterial testing.

From room-by-room cleaning validation to decontamination validation of the entire controlled area

In addition to routine cleaning, in our facilities we have installed a broad-range automated decontamination system using peracetic acid, which has been developed in-house. We thereby achieve complete decontamination independent of the level of experience of the operators by regularly decontaminating the entire controlled area, including the back side of installed machinery and other hard-to-reach areas. Decontamination validation is performed using a biological indicator.

3. Eliminate Cross Contamination and Mistakes

Mechanism of isolation control implemented strictly for each project

Our CPC envisions the progression of multiple projects at the same time, and can provides completely isolated and independent work spaces by enforcing access restrictions through non-contact active tags for each room. The ingredients and materials for each project are stored in a dedicated supply room with restricted access.

Effort to prevent erroneous use through the cell processing operation control system

We have created a mechanism to prevent human errors with double-checks by the operator and checker, and matching of 2-D codes generated by the cell processing control system. A history of all processing activities are now managed through this mechanism.

Elimination of cross contamination with independent air-conditioning ducts and flow line control

Each processing room has isolated air circulation ducts, so that there is no mixing with air from other processing rooms used for different projects. In addition, interlocking doors and human traffic management are implemented, and thereby collectively cross contamination is prevented.

4. High Confidentiality and Security

Hierarchical control of room access and dedicated building

Access of personnel to certain rooms in the facility such as CPC, Cell Storage Room, and document archive is controlled according to their authority level. In addition, our manufacturing facilities are located within a building completely occupied and controlled by PharmaBio. Therefore, unlike office complexes or composite facilities, our building is not affected by accidents caused by neighboring tenants or power outages due to building maintenance. The entry/exit to the building is controlled exclusively by PharmaBio and a contract security company; this enables us to maintain high-level security and confidentiality.

5. Emergency Back-up Plan

Automated response in event of disasters

Power outage is a serious problem for manufacture of cell-based investigational new drugs. Next to the PharmaBio building, we have established a power generator for large-scale antidisaster facilities (rated output 60Kw/min). The CPC air-conditioning, equipment, storage equipment, culturing equipment and various monitoring/control systems, which are essential to maintain product quality, are automatically backed up in the event of a power outage.

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Our team of specialists provides comprehensive integrated support for contract development and manufacturing of cellular therapeutic agents.