EBMT-EHA CAR-T 2019 | CAR T-cell therapy from a hospital perspective
Christian Chabannon, MD, PhD, of Paoli-Calmettes Institute, Marseille, France, speaks at the 1st European CAR T-Cell Meeting, held in Paris, France, co-organized by the European Society for Blood & Marrow Transplantation (EBMT) and the European Hematology Association (EHA). Prof. Chabannon explains the issues in the manufacturing of CAR T-cells, and emphasizes the need for auditing and qualifying in hospitals and blood banks that are involved in the production process.
Transcript (edited for clarity):
CAR T-cells raise specific issues in terms of manufacturing. Hospitals are part of the manufacturing process since it provides the starting material to the industry manufacturer, and that needs to set in place a specific organization. That also means that hospitals or blood banks, being suppliers or manufacturers, will be audited on a regular basis and will need to comply with some of the requests of the good manufacturing practices.
We’ve identified, and all the stakeholders have identified, many bottlenecks in the access to these treatments. As I mentioned before, hospitals need to be qualified by the manufacturer in order of the marketing authorization before they can start to deliver the treatments. In some institutions, that needs upgrading the cell collection and the cell processing facilities and organizations.
Another bottleneck is the capacities of the manufacturers to actually produce the product. Whenever you envision to treat a patient with CAR T-cells, you first have to coordinate with the manufacturer and make sure that the slot is available at the manufacturing plant.
The return of the drug product to the hospital again raises specific issues. Since this is a medicinal product, this is under the responsibility of the hospital pharmacists. But the technical infrastructures and capacities are usually within a cell processing facility where different categories of personnel work. So these two different areas of personnel, pharmacists and personnel at the cell processing facilities, need to get coordinated.
When we move to the clinical aspects of CAR T-cells administrations, that also request a specific organization to deal with the side effects and how, for example, you interact with the intensive care unit in case your patients develop severe cytokine release syndrome. You need to have the organization in place to care for your patient without further delay.
So all of these aspects have created challenges to the hospital organizations, and this is one of the goal of the EBMT, for example, to provide solutions that could be used at every center in order to facilitate access to these therapies.
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