Cryo-Cell Opens New Business Hub in Durham North Carolina

The family cord blood bank Cryo-Cell International has launched a new operations center in Durham, North Carolina. Cryo-Cell has started to operate the cryogenic storage area of a 56,000 square foot building located about 5 miles down the road from the Duke University Medical Center.

The move to Durham was driven primarily by the relationship that Cryo-Cell has with Dr. Joanne Kurtzberg’s team at Duke University. Cryo-Cell has an exclusive licensing agreement to commercialize the cord blood and cord tissue manufacturing methods and the therapies developed at Duke University. Initially, in 2021 Cryo-Cell purchased space in a medical office park near Duke to set up an infusion clinic. However, various delays occurred in the process of obtaining approval for the next steps in the Duke pipeline of clinical trials and compassionate use programs. Meanwhile, Cryo-Cell decided to consolidate most of their new business ventures into one space. Hence, they sold the office park space and instead in July 2022 they purchased a brand new 56,000 sq ft building. Over the past two years, Cryo-Cell has proceeded to outfit this huge building with the infrastructure necessary to convert it to a biotech operations facility.

The rough floor plan of the Cryo-Cell building is outlined in the figure above. Visitors will enter the building through a central lobby. To their left will be all the clinical operations, and to their right, behind a glass wall, will be all the laboratory operations. The entire back of the building is given over to cryogenic storage space. The scale of this building is so big that the central hallway running the length of the building is 130 yards (119 meters) long.

Currently, the only part of the building that is 100% complete is the cryogenic storage area. Cryo-Cell has recently moved many of the dewars that hold their own client’s cord blood into the Durham storage facility, and has notified their clients of the move.

Cryo-Cell intends to market their state-of-the-art biobank storage space as a third-party storage service under the name ExtraVault. The cryogenic storage area in Durham is equipped with multiple rows of double-jacketed vacuum-insulated steel pipes carrying liquid nitrogen (LN₂) from their 13,000 gallon storage tank. The building has the capacity to hold 226 large LN₂ dewars. Cryo-Cell has spared no expense with safety. For example, the storage area has three different oxygen (O₂) monitoring systems to protect the inhabitants of the building in the event of a nitrogen leak. One safety system shuts off the flow from the LN₂ tank, a second is connected to the central monitoring system which alerts the staff, and the third has seven O₂ monitors connected to the HVAC system which trigger an increased flow of outside air to dilute any LN₂ in the air within the facility. Cryo-Cell has an additional storage area which can accommodate 200 “mechanical” (electric) low-temperature freezers. The electric supply of the building is backed up by a 300kW natural gas generator which is connected by pipeline to the local gas utility. Cryo-Cell has plans to increase this generator capacity to 1.3mW as they expand. The building also has an automatic fire suppression sprinkler system.

As the remainder of the Cryo-Cell building in Durham is completed, it can be used for a mixture of Cryo-Cell projects and contracts to third parties. Cryo-Cell is leveraging their more than 30 years of experience maintaining cryogenic samples for potential transplant. Cryo-Cell has accreditation from FACT and AABB, and is a member of NMDP. Cryo-Cell has the expertise to ensure that their client’s specimens are stored in compliance with all regulations. The potential market for ExtraVault cryogenic storage includes academic centers, biopharma companies, and transplant centers. Once Cryo-Cell completes their approximately 11,000 sq ft of clean room space, they will be able to market their cellular manufacturing capabilities.

It must be emphasized that Cryo-Cell is not abandoning their headquarters in Oldsmar, Florida, any time soon. The laboratory and staff in Oldsmar have ongoing commitments to research partnerships with organizations in Florida. Nonetheless, the opening of the new building in Durham makes Cryo-Cell the first cord blood bank in the United States, and one of few in the world, to move beyond simply banking stem cells towards integration with cellular therapy manufacturing and clinical delivery of care.