Our Cell Processing Center

When we founded CellBank in 2004 hardly anyone had heard of regenerative medicine. But since then, we’ve worked to make regenerative treatments accessible by providing the highest quality cells available. In 2014 the Act on the Safety of Regenerative Medicine helped us achieve our goal of becoming a leading provider as we set up Japan’s first large-scale Cell Processing Center (CPC). With this new CPC we’ve been able to work with an even greater variety of cells to make regenerative treatments safer and more accessible for patients across the country.

Now the possibilities of regenerative medicine are growing. Each year we collaborate with new clinics to bring groundbreaking regenerative treatments to more and more patients. With our newly expanded Cell Storage Room, accessible regenerative medicine is more than just a dream.

Our Large-Scale CPC

A good Cell Processing Center (CPC) is an essential part of regenerative medicine. Our CPC operates 24 hours a day in a fully sterile environment to ensure that we only cultivate the highest quality cells.

Our large-scale 298.82㎡ CPC is accredited under the Act on the Safety of Regenerative Medicine. After undergoing inspection by the PMDA (Pharmaceutical and Medical Devices Agency), we received our official Accreditation of Cell Processing (institution no. FA3150017) on November 9, 2015.

Monitoring Zones

We carefully monitor and record temperature, humidity and cleanliness at our CPC 24 hours a day. Our CPC is divided into 4 Monitoring Zones (A-D) to keep the facility fully sterile at all times. Monitoring Zones are based on air quality, and each has its own set of careful management standards. Zone A is the most sterile zone, limited to only the most highly trained specialists. This is where cell cultivation happens.

Our CPC is single entry, single exit. When Cultivation Specialists head to the Clean Zone for cell cultivation they must first follow a series of strict entry guidelines. After carefully washing their hands, Specialists change into two sets of sterile clothing before moving on to the Clean Zone. When Specialists leave at the end of the day they change out of their sterile clothing in a different area. This system helps us prevent outside contamination and keep the cell cultivation environment fully sterile.

We carefully manage our CPC under the guidelines of the Act on the Safety of Regenerative Medicine.

Our management standards are based on 3 main points: ① Eliminating errors, ② Preventing contamination, and ③ Quality Assurance.

① Eliminating Errors

The entire cell cultivation process from production to quality control is handled by a designated supervisor. Our supervisors manage cell processing through a strict documentation system to eliminate potential errors. Everything is carefully verified, cross-checked and approved. We also use a barcode system to organize everything from cell samples to cultivation reagents, and verifications are always done in teams of 2 to ensure accuracy.

② Preventing Contamination

We have a strict sanitation system to prevent cross-contamination throughout the cultivation process. Everything in our CPC from clothing and hand washing to sanitation of equipment is carefully managed under this system. All of our sanitation procedures are recorded.

③ Quality Assurance

It’s important to carefully manage cell samples throughout the cultivation process so each and every one of our patients can enjoy the highest quality treatment possible.

Our CPC has a strict quality management system (QMS) to ensure that we’re always providing safe, high quality cells.

Accessible Treatments

Large-scale cultivation, strong R&D and a careful provision system are all key parts of accessible regenerative medicine.

But with no standardized system for regenerative medicine treatments can be expensive and hard to come by. At CellBank we're working to make accessible regenerative medicine a reality. Our goal is to make regenerative medicine streamlined, safe and affordable for everyone.

Regenerative treatments are one of the biggest breakthroughs in modern medicine. A high level of technical expertise, specialized equipment, a strong management system and highly trained specialists are all essential for quality regenerative medicine. But it can be hard for most clinics to implement highly specialized treatments. Because of this regenerative medicine has only been available to a small number of patients at a few highly specialized facilities.

Regenerative treatments are one of the biggest breakthroughs in modern medicine. A high level of technical expertise, specialized equipment, a strong management system and highly trained specialists are all essential for quality regenerative medicine. But it can be hard for most clinics to implement highly specialized treatments. Because of this regenerative medicine has only been available to a small number of patients at a few highly specialized facilities.

CellBank is working to revive regenerative medicine as a treatment option available to anyone by providing total support for the implementation of regenerative medicine at other medical facilities through our unique knowledge and experience. In 2020, 14 medical facilities began offering regenerative medical treatments in collaboration with CellBank.

At CellBank, we want regenerative medicine to be accessible for everyone. Our comprehensive institutional support makes it easy for clinics to offer regenerative treatments. In 2020 alone we partnered with 14 new clinics to make regenerative medicine a possibility for even more patients across the country.

Each "thank you" from a patient makes our work here at CellBank worth it. That’s why we want to make regenerative medicine accessible for everyone.