Phicell Corporation
Phicell Corporation is a specialized cell storage and transportation company, operating several GMP-compliant facilities throughout Japan. We have successfully managed over 54 cell storage projects since our inception in 2017, and annually handle over 93,000 shipments of specimens, biological materials, pharmaceuticals, products for regenerative medicine, and investigational drugs.
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Our cell storage facilities are strategically positioned where the world’s most advanced supercomputer “Fugaku” is running disaster mitigation simulations, ensuring minimal risk from natural disasters. Furthermore, our BCP measures include secured backup power during outages and a comprehensive temperature monitoring system for our facilities.
We also ensure that all stored cell information is anonymized and securely managed within data centers in Japan, compliant with the General Data Protection Regulation (GDPR). Moreover, We are ISO 9001 certified, confirming our comprehensive quality management system.
Cell Storage
We are responsible for the storage and management of samples, specimens, and cells which require stringent procedural and quality controls, on behalf of researchers in research and development companies and academia. Our projects accommodate a range of durations, from as short as one month to long-term storage of over ten years.
Customers can select from a variety of storage temperature options to suit their storage material (-150°C, -80°C, 4°C, etc. zones). Since we have experienced personnel with backgrounds in research laboratories, we can support the research and development of complex biopharmaceuticals and other products.
We are not limited to lot management by the box but also offer specimen management by bottles, which allows for opening of boxes and partial pick up and dispatch. Furthermore, We are equipped to handle flexible warehousing and shipping operations.
Transportation
Our group company in charge of transportation, SAROUTE Co., Ltd., has a fleet of over 300 vehicles and trained drivers specialized in cell transportation across Japan. For over 25 years, they have been transporting cells, culture media, and investigational drugs in accordance with PIC/S GDP and ISO 9001 standards.
Our trained drivers are well-versed in the unique circumstances of medical institutions in Japan, making them a strong ally for foreign companies entering the Japanese market. Smooth collaboration with major domestic and international forwarders such as JAL, FedEx, and DHL are also a strength.
We also have several staff members with IATA DGR (Dangerous Goods Regulations) qualifications. Moreover, to minimize the impact of heat waves, we utilize the 24-hour operations at Narita International Airport and Kansai International Airport during nighttime hours for loading and unloading international cargo.
Our Strengths
Location
In Japan, where natural disasters are common, we place the utmost importance on BCP (Business Continuity Plan) as a condition for the location of our cell storage facilities to be entrusted with valuable cells from our customers.
Our site was affected by a magnitude 7.3 earthquake that struck the southern part of Hyogo Prefecture in 1995. From that experience, the location now has ground less prone to liquefaction and embankments built to withstand tsunamis.
Due to its elevation of seven meters above sea level, makes it impervious to hurricane tides, flooding, and storms.
Additionally, there is no concern of damage from volcanic eruptions, forest fires, or mudslides. Above all, the disaster mitigation simulations are being conducted by the world’s leading supercomputer “Fugaku,” located right next to the site.
BCP Measures
We spare no expense in investing in our BCP. As a power outage measure, we combine emergency generators, emergency batteries, and auxiliary cooling cylinders to provide backup for over 12 hours from the onset of trouble, ensuring a response until power is restored. The temperatures of our storage facilities at -150℃, -80℃, and 4℃ are monitored in real time by our temperature monitoring system. The liquid nitrogen tanks for -150°C storage is refilled with liquid nitrogen through automatic control.
If an alert is issued by the temperature monitoring system, the responsible personnel contacts the 24/7 security office and takes measures according to the emergency manual. Should there be no anomalies with the building, and if individual freezers or coolers fail, the auxiliary cooling system activates concurrently with the alert. In addition, a large in-house power generator is also available as a reserve power source.
Data Security
We wish to emphasize our commitment to data security. Our nation is compliant with the GDPR (General Data Protection Regulation). We have our own cell storage management system developed in-house, and although we use cloud technology, we plan to continue limiting our data centers to those within Japan. Furthermore, all information about the cells we store is anonymized.
Compliance with Quality Standards
Next, we’d like to discuss about our quality management system. We are ISO 9001 certified and are in the process of applying for pharmaceutical manufacturing approval. We have documented SOP (Standard Operating Procedures) that comply with GMP, and during the installation of equipment and machinery, we perform IQ (Installation Qualification), OQ (Operation Qualification), and PQ (Performance Qualification). We also conduct annual OQ and PQ for each storage unit.
Regarding staff training, new employees undergo three months of daily training in GMP, GCP, and GDP, gaining knowledge and experience through classroom learning and on-the-job training. Subsequently, only those who pass the exams can work on-site. They then gain experience in handling cells through validation work, regular report preparation, and support roles for veteran employees. In addition, wet lab workers receive hands-on training from veteran employees and must pass before engaging in actual work.
Not to mention, continuing education of over 20 hours per year is mandatory, where employees learn about crucial topics such as BCP and emergency preparedness, updates on relevant laws and regulations, and pharmaceutical market trends.
We also have a thorough access control system for our storage facilities. In addition to 24-hour manned surveillance, entry is not possible without clearing all security measures including card, ID, and biometric authentication. Upon entry, visitors change into work clothes and indoor shoes to minimize dust infiltration.
Adjacent to the cell storage room, there is a room designated for the transfer of cells, where the storage and delivery areas are clearly separated. This room is also temperature-controlled, where cells are packed, temperature logs during transportation are checked, and cells are handed over after unpacking the transport box. Different procedures for each protocol are shared in advance between transportation and storage personnel, minimizing the time cells are exposed to room temperature during operations.
We also invest in the safety of workers within the cell storage room. Remote monitoring cameras are installed, and oxygen concentration is monitored. Additionally, workers wear fall sensors that alert team members outside the room in the event of a non-environmental fall.
Service Use Cases
Clients use our services as an outsourcing company for research and development support for pharmaceutical and regenerative medicine products. Regarding cell storage, customers can use the service when they want to have distributed storage sites for cells at multiple facilities as a BCP measure.
For transportation, customers can use the service for the following purposes:
- As a collection point prior to international shipping
- As a domestic distribution center (depot) for clinical trial drugs and cell preparations, etc.
Subsequently, we also provide support for the preparation of related materials, such as specimen storage containers and ID labels affixed to these containers, as an adjunct to storage consignment. We also have wet labs for pre- and post-storage dispensing work.
Cost Examples (For Reference)
- An example of cell storage fees: For storing 81 vials of 2 mL each, the cost would be approximately 70,000 Japanese yen (equivalent to about 482 USD at an exchange rate of 145 yen to the dollar).
- An example of shipping fees: To ship 81 vials of 2 ㎖ each from Kobe to Tokyo, a distance of approximately 500 km, using a mix of air and ground transportation with the temperature condition set at minus 20°C, the cost would be around 70,000 Japanese yen (approximately 482 USD at the same exchange rate). However, this excludes fees for options such as temperature loggers.
Track Records
In the six years since our founding, we have a track record of 54 cell storage projects and annually handle over 93,000 shipments of specimens, biological samples, pharmaceuticals, products for regenerative medicine, and investigational drugs.
We carefully handle everything from large-scale international clinical trials conducted by Japan’s top three major pharmaceutical companies to small-scale physician-led studies by academics. We have a proven track record with clients across corporations, universities, and public research institutes, and our procedures meet high standards due to audits by multiple major pharmaceutical companies.
Contact
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