• Zeitkritischer-Transport

Getting a patient’s time-critical fresh apheresis cells from Atlanta, USA, to a Good Manufacturing Practice (GMP) facility in Nuremberg, Germany, within 18 hours (Part 1).

The mission: Fresh cells have only a limited shelf life outside of the human body. Hour after hour, even minute after minute, cells lose viability and fitness and form clumps, making manufacturing in a GMP facility impossible. In a clinical trial with fresh white blood cells as starting material, apheresis cells from regional hospitals could be delivered for manufacturing within a few hours. But how could overseas patients be served from the same GMP facility without changing the entire established set-up?

The challenge: A biotech company initiating a clinical trial in the field of cell therapy contacted us with a time-critical request: to transport fresh cells from Atlanta to a GMP facility in Nuremberg within 18 hours max. Although the apheresis was scheduled several days in advance, the urgency of the transport remained due to the very short life span of the collected cells. For the customer, a long transport time would be serious, as he would have to discard the cells. This would mean he could not provide treatment to the waiting patient.

The transport: As time was so short, we decided to have the sensitive cells accompanied by a medical On Board Courier. Our Stem Cell Team chose an experienced stem cell courier who had already performed several transport missions in this field. The courier arrived on Tuesday in Atlanta one day before the apheresis to make sure he was in place for the pick-up at 12:00 pm/noon on Wednesday. To maintain the right cell temperature (20-25°C including temperature monitoring), the courier brought with him a conditioned high-performance temperature box. The blood collection took longer than scheduled that day, so the courier picked up the cells at 12:20 pm/noon at the collection facility. He then went to the airport, passed the security check and prepared for the flight. Since such sensitive cells must not be x-rayed, we prepared a statement which would allow the courier to ask for other checks at security. Depending on the cell type, cells may show increased sensibility, so we focused on ensuring our customer’s cells remained in the best possible condition. Our courier flew directly from Atlanta to Frankfurt. After arrival at 7:10 am on Thursday and completing customs clearance, the courier managed to catch the next train at 8:30 am. The handover in Nurnberg to the trained GMP technician took place at 12:30 pm/noon.

The result: The cells were delivered within the 18-hour time frame and were used to manufacture a functioning cell therapy product. Stay tuned to find out about the second and third leg of this cell therapy supply chain.

Stay tuned: The second part of the transport story will follow shortly.

Life & Health
September 6th, 2018|