Supporting development activities with fully reliable security and backup
Intending to contribute to development of cell-based medicinal products, PharmaBio has established Cell Processing Center (CPC) in our Nagoya Contract Manufacturing Facility which is adaptable to regulatory standards in various countries. We are committed to support regulatory affairs and R&D activities pertinent to drug development, while strictly protecting customer’s confidential information and invaluable products through our state-of-the-art security and backup systems.
Introduction of Our Nagoya Contract Manufacturing Facility
Our Nagoya Contract Manufacturing Facility is fully equipped to satisfy a variety of contract needs related to drug development. In addition to Cell Processing Center (CPC) designed in accordance with GCTP standards, our resources include Cell Preservation Room equipped with multiple backup systems, Quality Testing Lab adaptable to various quality tests, Sterile Room, and Viral and Bacterial Test Lab. We are committed to support regulatory affairs and R&D activities, while protecting customer’s confidential information and invaluable samples and products with our airtight security system and multi-layer backup system.
For PharmaBio’s Facility Design Policy, please see here.
Cell Processing Center (CPC) -GCTP Clean Rooms
Our CPC has 3 clean rooms, which are fully independent from each other. Access to these rooms is controlled on a project-by-project basis, so that personnel working on other projects never enter the room used for your project. All work process-related files are computerized and associated with work records and environmental monitoring data, thereby ensuring traceability.
Cell Storage Room
We understand how valuable customers’ samples stored in our Cell Storage Room. That is why we control the access to this Room with a double-layered, active tag plus biometric authentication system and monitor the Room continuously with surveillance cameras. For cell preservation at a minimized risk of contamination, we have adopted a vapor-phase (-190℃) liquid nitrogen storage container. The container is continuously monitored for the liquid nitrogen level and liquid nitrogen is automatically supplied from an external liquid nitrogen tank when necessary. Temperature data are also constantly monitored and, if a deviation is found, multiple operators are notified by an emergency e-mail notification. The system has two lines of power supply, normal and emergency supplies, which ensures your samples being protected with our reliable backup system even in emergency situations.
Quality Testing Lab
In Quality Testing Lab, a variety of the latest analytical instruments/equipment are available to allow a wide range of quality control/assurance tests, including raw material acceptance tests, in-process quality tests, and release tests. Specifically, the Lab is adaptable to cell morphology analysis, proliferation rate and cell viability determination, flow cytrometry-based surface antigen profiling, immunoassays such as ELISA, and nucleic acid sequencing with DNA sequencers, among other tests.
Our Sterile Room is equipped with isolators and incubators, and is used to conduct, for example, sterility tests, aseptic procedures such as preparation and dispensing of culture media, and tests requiring cell culturing. Decontamination validation is also conducted in this Room for each test using our latest decontamination system.
Viral and Bacterial Test Lab
In this lab, tests to rule out the presence of viruses and microorganisms,mycoplasma, and endotoxins in raw materials and in-process materials. Our Viral and Bacterial Test Lab is registered as a clinical laboratory and microbial genetic test of clinical specimens is conducted in this lab, so it can also be used for donor screening.
Thorough monitoring and recording using various control systems and monitoring systems
We work with critical confidential information and invaluable products and specimens that customers trusted to us. To securely protect them and meet the highest quality standard, our Contract Manufacturing Facility is protected by advanced security and backup systems, and is under thorough monitoring and recording by various control and monitoring systems.
Visitor access to our building is restricted with a biometrics authentication system (finger vein authentication) at the entrance. Inside the building, room access is controlled on a room-by-room basis using noncontact tags. Access to critical areas such as Cell Storage Room and Cell Processing Center is controlled by an additional layer of biometrics authentication, and entering/exiting are recorded.
Surroundings of the building and critical facilities are under surveillance and recording by image monitoring.
Environmental monitoring system
The multipoint environmental monitoring system ensures that the differential pressure, room temperature, particle number, CO2 concentration, and culture temperature in clean rooms, and the internal temperature of the cell storage devices in the Cell Storage Room are always recorded and monitored, and multiple operators are notified by emergency notification e-mails, when deviation is detected.
Various control systems
All work process-related files for cell processing are computerized by the cell processing operation control system, which associate them with operation records and environmental monitoring information to ensure traceability. The sample management system records the storage location and history of incoming and outgoing for each and every sample stored in the Cell Storage Room.
A power generator for large-scale anti-disaster facilities (rated output 60 Kw/min) is in place for potential power outages in the event of disaster, which backs up important equipment including clean room air-conditioning, CO2 incubator, refrigerator, ultra-low temperature freezer, liquid nitrogen storage containers, and various monitoring and control systems. Storage devices have backup systems in the form of the subsidiary cooling system and the automatic liquid nitrogen supply system.