Innovative cell therapies require flawless logistics. Any failure in the process might have fatal consequences for the patient. Find out more about the complicated logistics of extracorporeal therapies and how innovative digital solutions can help to make these therapies a safe reality for patients.
Therapies based on extracorporeal cell or tissue processing have left the status of a vision. They are becoming reality. A good example are the CAR –T cancer therapies KymriahTM (acute lymphoblastic leukemia) and YescartaTM (large B-cell lymphoma), which have already been approved by FDA and are available on the market.
How do these treatments work? In a few words:
Cells become extracted from the patient. Thereafter, these cells are shipped to a pharma site, become processed, are shipped back and
re-administered to the patient.
But what does that mean for the logistics of such sensitive and life-saving shipments? At last year’s LogiPharma in Montreux, Hypertrust Patient Data Care GmbH launched the Hypertrust X-Chain solution, a patient-centered blockchain-enabled platform which supports and protects the treatment process of extracorporeal cell or tissue therapies with ideal processes and technologies.
What is unique about extracorporeal cell and tissue logistics?
First, it is the background of each shipment. E.g. in case of
CAR-T therapies, besides the costs for such treatments, each shipment is intended to save a human life and the affected patients often have no more time for a second attempt.
But also from the technical point of view, it is not just a cold chain or an cryogenic-state chain. It is a closed-loop supply chain. The patient is the starting point and the end point of a complex distributed manufacturing process, spanning across the entire supply chain. Throughout the treatment process, the chain of custody must be seamlessly auditable for each process step and each handover.
Transportation planning
In extracorporeal cell and tissue therapies, risk mitigation already starts prior to transport planning. Each leg of each available route must be assessed for duration and risk rating. There are several methods available to achieve a good risk rating (e.g. Fault Tree Analysis, Event Tree Analysis, Failure Mode and Effect Analysis, Markov Model Chain, Hazard and Operability Study…). During routing and scheduling, the specified route must be validated for duration and risk rating.
Subcontracting
Subcontracting is indispensable in the world of worldwide transports. But a chain is only as strong as its weakest part, which also applies to your supply chain. Every third party who comes into direct or indirect contact with the shipment, i.e. the patient’s cells, must be regularly validated. Also, these parties need to adhere to the latest IT security standards in order to join the tune of such a heavily mixed orchestra.
Packaging and transport units
The cold chain must be maintained under all circumstances, which starts with the right packaging. This includes the usage of validated and certified packaging material.
The (static) holding time is a good indicator how long a package can keep the temperature below a certain level. The dynamic holding time indicates how long this works when the shipment is in transit. However, this is changing when data loggers become attached, so validation must take this into account.
Data loggers are extremely important for detecting issues and short-term reactions.
Good data loggers report a multitude of parameters in real time, such as:
- Internal temperature
- External temperature
- Location
- Orientation
- Light
- Humidity
- Pressure
For cryogenic ultra-cold chain shipments, dry shippers are required. These dry shippers must be prepared before use, amongst other things by filling with liquid nitrogen. Liquid nitrogen boils at -196 °C and is used to keep the temperature constant below –150 °C.
Dry shippers are the key element of the cryogenic ultra-cold-chain. Therefore, the lifecycle of a dry shipper must follow a strict protocol: preparation, use, return, cleaning, maintenance, replacement of consumables, test and revalidation. Compliance with the protocol must be documented at each step.
Transport execution
During transport execution, monitoring is of highest importance. Checking data loggers as often as possible (e.g. at every shipment handover), just provides a minimum of monitoring. Wherever possible, real-time monitoring should be used. Real-time monitoring allows to identify emerging problems and to trigger countermeasures immediately.
This type of active monitoring allows interventions and works as follows:
In case a dry shipper is upset, holding time is reduced. An orientation sensor detects the event and reports it to the control tower. The control tower responds and commands the driver to stop, to straighten up the dry shipper and to check the load securing. In this way the consequences of the disturbance can be minimized.
Customs
Customs clearance is another complex issue. For example, Germany has its own national export regulation of much-needed goods of human origin for life-saving measures. Importing the processed cells or tissue involves another party as it may need an import authorization from the National Food and Drug Administration. They will check whether the import complies with the Food and Drug Law, which is a national law. Therefore, it requires some alignments in advance with the relevant authorities to exclude any avoidable interruptions during customs clearance.
How Hypertrust X-Chain helps to solve this challenge?
Hypertrust X-Chain is a platform that seamlessly accompanies the
end-to-end process of extracorporeal cell therapies across all stakeholders. It provides tools to help support the respective stakeholders and uses blockchain technology to make the process auditable at all times. The easy integration into the existing IT landscape makes the X-Chain nearly invisible to most end users.
Furthermore, the so called “Hypertrust Workchain”, a blockchain based workflow engine, guarantees the strict adherence to formerly validated process steps, completely resistant to changes through hacks, viruses or trojans.
Hypertrust X-Chain has been developed by Hypertrust Patient Data Care, a CAMELOT Group spin-off. CAMELOT is a leading consulting specialist for value chain management especially in the life sciences industry. For more than 20 years CAMELOT has been a trusted partner to many leading life sciences companies and helped them build excellent patient-centric value chains that are agile without jeopardizing profitability.
You want to know more?
If you want to know more about the Hypertrust X-Chain solution, its benefits for your organization and how it works, just get in touch with us.
We would like to thank Christoph Bumen for his valuable contribution to this article.
