The Cell-in-a-Box® live cell encapsulation technology employed by PharmaCyte Biotech is a “platform” upon which treatments for different diseases may be built. This technology encloses living cells in protective “cocoons” or “capsules” about the size of the head of a pin. The live cells inside the Cell-in-a-Box® capsules are nourished and thrive while the capsules are in the body and are protected from attack by the body’s immune system because they cannot escape from the capsules and immune system cells cannot enter the capsules and destroy them. The focus of PharmaCyte Biotech using this technology is to develop treatments for various forms of cancer, particularly pancreatic cancer, for abdominal cancers, for breast cancer and for diabetes.
The encapsulation of living cells using the Cell-in-a-Box® technology is a multi-step process. The live cells to be encapsulated are first suspended in a medium that contains a proprietary polymer and sodium cellulose sulfate. This suspension is passed through a droplet-forming machine and the resulting droplets fall into a solution containing another polymer. Immediately, as the two polymers interact, a membrane forms around each droplet. This ultimately develops into a “shell” around the droplet, resulting in a spherical capsule 0.7-0.8 mm in diameter. For pancreatic cancer, each capsule ultimately contains about 10,000 cells. This number can differ depending upon the size of the cells encapsulated and for what purpose they are to be used.
The capsules produced using the Cell-in-a-Box® encapsulation differ from those produced by others. Our competitors use substances such as alginate (a seaweed derivative) or chitosan, whereas our capsules are made principally of cellulose, a bio-inert material in the human body. The Cell-in-a-Box® capsules are robust and can withstand various external forces unlike those made using other encapsulation methods. This robustness of our capsules allows them to be implanted in the human body by using needles or catheters without damage. Our capsules do not degrade, even after being present in the body for over two years, and they do not cause any damage to, or inflammation of, tissues near where they are located in the body.
Cells encapsulated using the Cell-in-a-Box® technology can be stored frozen at -80°C or lower for long periods of time and then successfully thawed – a necessity for shipment to distant locations. Large-scale manufacturing of encapsulated cells using this technology has been carried out according current Good Manufacturing Practice (cGMP) conditions – a necessity for ultimately attaining marketing approval from drug regulatory authorities, such as the U.S. FDA.
PharmaCyte Biotech has acquired the worldwide exclusive rights to this live cell-encapsulation technology for the development of treatments for all types of cancer and for diabetes. The rights to use the cancer prodrug-activating cells that will be part of our treatments for advanced pancreatic cancer and breast cancer were also acquired.
The Cell-in-a-Box® Live Cell Encapsulation Facility
Because of the requirement that cGMP-compliant material be used for clinical trials, PharmaCyte Biotech’s partner, Austrianova, has constructed and equipped a cGMP-compliant facility in the Thai Science Park in Bangkok, Thailand The facility will be used to carry out the Cell-in-a-Box® live cell encapsulation process. Once the facility has been has been deemed “satisfactory” for use by drug regulatory authorities, production of capsules can begin in preparation for PharmaCyte Biotech’s various clinical trials discussed in other sections of this website.