Achieving Irrefutable Chain of Custody for Cell & Gene Therapies with Smart Technologies

Cell & Gene Therapy Chain of Custody

Chain of custody (COC) in the simplest of terms, details the location and time an item changed hands and who delivered and received the item. There are COC requirements for pharmaceuticals in every country to ensure patients receive genuine, viable medications. For cell and gene therapies, the COC must be flawlessly executed and requires even more data collection and documentation.

From the initial collection of raw material from the patient and administering the final treatment, the number of hand-offs and processes involved is vast and complex. As an example, last year, Thermo Fisher Scientific (TFS) published an article on the importance of COC documentation for biologics. It references all of the points of documentation required when shipping materials to a clinical site for patient administration:

  1. Shipper hand-off to courier
  2. Courier hand-off to TSA screener at departure airport
  3. Hand-off to TSA screener at arrival airport
  4. TSA screener hand-off to courier
  5. Courier hand-off to dosing center staff
  6. Hand-off to pharmacy staff who then documents the time, date and temperature of the therapy when placed in storage in the pharmacy

And that’s just a portion of the entire COC. All of these hand-offs present one large area of risk, but there are others.

PCI Clinical Services published a white paper not long ago where they identified five key risk factors relevant to the six primary stages of the cell and gene supply chain. It will come as no surprise to anyone that temperature excursions ranked as high risk at both ends of the supply chain and time excursions were labeled high risk for starting material and medium risk for therapy delivery in the example they used. I would stipulate that, more often than not, time excursions would also be high risk at both ends.

Given that the risks we’re discussing could prove fatal to a patient, COC is absolutely crucial and must be completed without error. This is where smart technology can help improve the commercialization process for these therapies by automatically collecting data throughout the shipment process in each direction and providing alerts about any temperature or time excursions and protect against mishandling.

A real-time tracking device integrated into the packaging along with cooperation from various partners in your supply chain will allow cell and gene therapy manufacturers to have visibility into:

  • Shipment departures and arrivals using facility location geofence
  • GPS location while on the ground providing details on speed of transport and any idle time
  • Temperature alerts that allow quick reaction to prevent excursions
  • Impact/shock events

For the cell and gene therapy industry, this real-time visibility allows for COC confirmation as well as the ability to intervene in the event of an excursion. It also supports patient identity tracking throughout the shipment. Along with considerable benefits for COC, a smart tracking device can collect considerable data during the shipment process that will provide proof of increased industry and regulatory compliance and GDP requirements.

Chain of custody is important for every shipment, but the implications for a broken COC in the cell and gene supply chain can be the difference between life and death for a patient. By integrating smart technology throughout the supply chain you can protect your COC, your product, and your patient.