Such revolutionary and life-altering treatment requires careful attention to the multiple steps required for production and delivery. The process of washing, concentrating, transporting, modifying and transferring cells into the same or another human being is not without risk.
Limiting the number of steps and parties involved minimizes many of these concerns, as well as ensures treatment is as widely available as possible. That’s why GE Healthcare Life Sciences recently acquired Biosafe Group. GE says the deal will bring key cell therapy innovations under the same roof.
Biosafe is based in Eysins, Switzerland, with a sweeping view of Mont Blanc. The company makes the equipment used to manufacture a number of cell therapies. For example, the process for cancer therapy works like this: Doctors collect certain blood cells, known as T cells, with a special device over the course of a few hours. The cells are then transported to a lab either in the hospital or in a separate location. At the lab, the cells are genetically modified to attack the cancer, expanded in cell culture to produce sufficient cells for a therapeutic dose and then transported back to the hospital to be administered to the patient.
An image of a white blood helper cell taken by the GE's Delta Vision OMX microscope.
Combining GE’s and Biosafe’s technologies promises to make the process more efficient and lower the risk of contamination and other safety concerns, Vanek says.
“The whole process of handling cells, making sure the system is closed so that there’s no risk of contamination from exposure to elements that might taint the process; you want to be able to replicate this process over time,” says Morrie Ruffin, managing director for the Alliance for Regenerative Medicine, an advocacy organization representing the field of cell therapy, gene therapy and broader regenerative medicine. “Figuring out how to accomplish this is a very important part of what companies are investing in. Tremendous progress has been made over the last five to six years.”
For cell therapy to become truly mainstream, companies involved in the field will need to work closer together to build a stronger infrastructure.
“None of these therapies have been commercialized yet,” says Ruffin. “But there are several in late-stage trials now and we are expecting several of them to move into the registration phase.” Ruffin anticipates some may reach the regulatory approval phase as early as 2017.
A lung adenocarcinoma cell. In cell therapy for cancers, cells are genetically modified to attack the cancer, expanded in cell culture and then administered to the patient.
With the Biosafe acquisition, GE Healthcare is also getting a foot in the door of the growing market for stem cell treatment known as cord-blood banking. Biosafe got its start manufacturing the equipment that doctors and lab technicians use to transfer cord blood, found in the umbilical cord connecting newborns to their mothers. Cord blood is a key source of stem cells that could potentially be used in transplants. The other source is bone marrow, which is more difficult and expensive to extract.
Many new parents in U.S. and European hospitals currently have the option to keep the umbilical cord blood of their baby cryogenically frozen and banked, providing stem cells that could potentially be used to treat the child in the future, if needed. A Biosafe device known as the Sepax 2, which looks like a large coffee maker, is often used to wash and concentrate the cord blood cells before they are frozen. The Biosafe acquisition should make the processing “much more efficient,” Vanek added.
“This does de-risk and simplify the collection of cord blood,” Vanek says. Down the line, as costs inevitably come down, that could give more parents the opportunity to collect potentially life-saving “living” medicine for their own children. The promises for future treatments are endless.
Given the significant potential to develop truly transformative treatments, Biosafe isn’t GE’s only push in cell therapy. The company is partner in a new research center that’s being built in Toronto, Canada. In April, GE Ventures teamed up with Mayo Clinic and launched Vitruvian Networks, an independent technology company that uses advanced manufacturing and data analytics software to industrialize cell therapy.
Top image: A T cell, a type of white blood cell.