Technology Storage

Storage & Logistics

The process of creating an autologous therapy, from the leukapheresis process to it's production and back for infusion requires a well coordinated logistics support.

The therapy requires two separate cell collections from the patient—a tumour and a PBMC (apheresis) collection—and a process for the receipt, storage and distribution of the finished product.

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Tumour cell collection

The entire process begins with the creation of a kit which will be used to collect the tumour and a unique identification number to identify the tumour with the patient. This unique patient identification number (UPIN) is specific and will be used throughout the collection, manufacturing, distribution, and administration. This ID ensures the right drug is infused to the right patient. This kit will include a qualified shipper for transporting the tissue to an interim storage point. Using this kit, the tumor sample is collected and packaged for transport (via common carrier) to storage facility where it is received, inventoried and stored until ordered for manufacture. Once ordered, it will again be packaged in a qualified shipper and transported to the point of manufacture, where it is stored until manufacturing begins..

Apheresis collection

Timing and logistics are critical with regard to the apheresis collection, as the manufacturing process begins with the receipt of the aphaeresis bag. Unlike the tumor collection process, there is no interim storage step; however, as with the tumor collection, the process begins with a kit with all of the components required for an apheresis collection. The kit includes the patient-specific identification labels and collection containers as well as a qualified shipping container. The cells are shipped via carrier, with the addition of an important step—notification of the manufacturer that the shipment is on the way. The shipment is received by the manufacturer, the patient ID is confirmed, and the manufacturing process can begin.

Therapy returns to patient

Once manufactured, the dose or doses are cryopreserved and loaded into a qualified dry shipper for transport via common carrier to a distribution facility, where the material is received and inventoried. When the therapy is packaged to leave the manufacturing site, it is “acquired” for distribution to a patient. At the distribution center, the individual doses are inventoried and stored in vapor phase nitrogen until requested by a clinical/investigator site for patient use. Each requested dose is shipped in a qualified dry shipper by common carrier to the clinical site for administration. While simplified, this three-step description gives an overview of the basic movement of the APCEDEN® and constituent materials required in an autologous manufacturing process.

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