• Qualitätserhaltung-von-kryokonservierten-Dendritischen-Zellen-bei-einem-Transport-vom-Aufbereitungslabor-(GMP)-in-Nürnberg-zum-Patienten-in-Atlanta-(USA)

Transport part 2 of 2: Maintaining the quality of cryopreserved dendritic cells (DCs) during transport from the Good Manufacturing Practice (GMP) facility in Nuremberg to the patient in Atlanta (USA)

The mission: Autologous cell therapy products are transported in a cryopreserved state (frozen to -190°C) for their return from the GMP facility to the hospital in 80% of cases. The temperature of these products must be kept below -150°C during storage and transport in order to allow for better planning of treatment according to the patient’s health status and hospital staff rosters. This low temperature can be maintained for 10–14 days in a special container known as a dry shipper or dewar.

The challenge: Unlike a temperature-controlled box, a dry shipper is highly sensitive to poor handling. Therefore, care must be taken to avoid the container being tilted or jolted on the way to the patient, as may usually happen during handling at airports. Poor handling can lead to a marked temperature rise within the dry shipper. In the worst case, the product will become unusable if the dry shipper is loaded horizontally onto the aircraft and then left like this for the entire flight.

The transport: The dry shipper was prepared at the GMP (Good Manufacturing Practice) facility one day before departure. On Monday afternoon, a time:matters courier collected the dry shipper from the laboratory and brought it to the time:matters Courier Terminal (tmCT) in Frankfurt Airport. The shipment cleared customs the following day (Tuesday) and was loaded into the aircraft and fixed in place. One of our handling experts supervised the operation to ensure the dry shipper was loaded upright and then properly secured within the aircraft. As the process owner for handling processes at Frankfurt Airport, time:matters can ensure correct handling of the dry shipper. At 10:25 am on Tuesday, the dendritic cells were transported directly from Frankfurt (FRA) to Atlanta (ATL) on flight LH444. The dry shipper reached Atlanta at 3:05 pm local time the same day. Customs clearance and FDA (Food and Drug Administration) checks were successfully completed. The cells were available on time on Wednesday morning for the planned infusion at the hospital.

The result: We maintained full control of the dry shipper along the entire supply chain, thereby ensuring the quality of the cells. The cells were delivered with the expected quality and successfully administered to the patient.

Life & Health
septembre 5th, 2018|