GE Healthcare Life Sciences also has signed on to the emerging cell therapy business. It believes that the next logical step is an industrialized bioprocessing workflow. Its approach is to leverage expertise in protein and monoclonal antibody production to develop specialized separation and analytical tools. While cell therapy is a nascent market with some risks from a business point of view, GE is willing to invest based on its previous experience in biologics. Regardless, the most expedious path for GE to enter this market is through partnerships.
The company already has established two: one with the Canadian Centre for Commercialization of Regenerative Medicine on new product development and the second with the Karolinska Hospital in Sweden.
“We are working on three projects at the Karolinska,” said Firman Ghouze, Ph.D., director of the cell therapy group at GE Healthcare. “We are initiating several R&D activities to optimize stem cell growth using GE tools and Karolinska’s clinical know-how. We also are capturing the clinical workflows associated with the cells and clinical processes. Finally, we are working on a framework to address regulatory and reimbursement challenges from the customer’s standpoint.”
GE is taking an agnostic approach to developing technologies for cell therapy. It is building a process that is broad and independent of a particular customer’s stem cells and approach. The key steps in the process have been defined as separation of cell populations, expansion of cells with desired biological function, quality control, and administration, i.e., injection and sample tracking.
During the course of this activity GE is looking to develop new products and adapt existing bioprocess platforms, optimized for stem cell production. An example of the latter approach is the use of the WAVE bioreactor.
Also for monitoring and QC processes, GE just launched a small footprint cell analysis imaging platform (Cytell) that can be used to image cells throughout the workflow process.
According to officials at Akron Biotech, their goal is to utilize the firm’s knowledge and expertise to supply and manufacture raw materials and provide technologies and validated services for the regenerative medicine industry.
Claudia Zylberberg, Ph.D., president and CEO, said the company is working to enable a better transition from the preclinical research bench to the clinic under a well-documented manufacturing process. Their portfolio includes serum-free growth media, supplements, and cryopreservation media, human growth factors and cytokines, cellular scaffolds (e.g., human fibronectin, and human fibrinogen).
In addition to “regulated” products, Akron also offers assay development services and works closely with start-up cell therapy companies to help them move their cellular therapeutic products into clinical trials.