Cord Blood

Isolating cells without touching their surface is a way to avoid creating molecular activity or reactions. This is a key concept behind BiOE's cord blood closed-bag processing system, PrepaCyte®-CB. “We wanted to optimize negative selection—get rid of unwanted cells—to obtain a highly purified population or group of populations, without touching the cells,” says Michael Haider, president and CEO.

The process is biological rather than mechanical. “We use mother nature and various materials depending on the cell population we’re trying to remove.” Only a small amount of biologic is required, and simple gravity is used for cell isolation. Since the dynamic range of the biologic is broad, exact mixtures are not required, Haider adds.

Approximately 98.5% of all red blood cells are removed in about 30 minutes, leaving nucleated and stem cells. Total nucleated cell count is the industry-standard measurement for cord blood samples and directly correlates to patient outcomes in transplants. Few cord blood samples make the cut—only about 25% are suitable for banking; 75% are thrown out due to low volume or cell count.

Currently, PrepaCyte-CB is a class II device, which allows sales to institutions regulated by an IND. Dr. Haider says the company’s main focus over the next six months is to obtain FDA 510(k) approval, which will open up global markets and allow sales to private cord blood banks.

“We believe this is setting a new pathway and enablement where the biologic is an enclosed system at the time of manufacture and all the work occurs by the biological fluid. The FDA is moving toward tighter regulations. The industry needs to continue to improve on the quality of the material that’s transplanted into the patient —this is usually a life or death issue,” Dr. Haider adds.