Integrating and Orchestrating CGT Couriers to Support CGT Supply Chain

CGT Couriers

The Cell and Gene Therapy (CGT) industry is experiencing rapid growth in both the number of therapies and indications being targeted. This means patient populations are expanding, and the task of supporting this scaled-up activity rests with CGT supply chain partners. To reach more patients, partners across the supply chain like CGT couriers and manufacturers must collaborate effectively. 

Many nuances are associated with handling CGTs and their starting materials in transit. They must be handled with care, subject to the right conditions and timescales to preserve cell viability. They must also meet the regulatory requirements that human tissues are subject to. In order to demonstrate regulatory adherence, a chain of custody (COC) report is generally required. 

The chain of custody normally consists of documents relating to shipping and handling, as well as date stamped handovers. When tracked in real-time, the chain of custody shows who has the cells, meaning issues are more easily addressed. Some CGT couriers can support the provision of rich data such as temperature monitoring during transit. 

The Benefit of Efficient Courier Management Within Your Supply Chain

CGT developers and handlers must consider all relevant data privacy legislation such as HIPAA and GDPR. As with HIPAA and GDPR, it is important to consider the regional nature of regulations. As therapies approach commercial launch they tend to target new countries and this could mean new processes. 

When moving into new territories, knowledgeable local partners can be invaluable, however more partners can bring its own complexity. Again, and automated cell orchestration platform can help to balance this risk. The software can integrate multiple couriers and use rules to determine which courier can handle each shipment. 

Regardless of region, data regulations must be met and the audit trail (chain of identity or COI) preserved. For personalized therapies, a failure in the chain of identity could be fatal. Without a clear COI, the cells could be rejected, resulting in delays or additional treatment, compromising patient safety. 

The CGT couriers play a key role in the supply chain cycle. Shipping demands particular care and attention as a high-risk element of the supply chain. As these points of the cycle, the materials in transit are arguably least controlled. 

Maintaining and monitoring optimal cell storage conditions becomes harder in transit. As does tracking chain of custody as the shippers pass through many hands during transportation and customs clearance. Alongside patient scheduling, shipping is an area that is vulnerable to delays. 

External variables like weather conditions, accidents, or delays at transition points like customs impact shipping. The pre-existing challenge of scheduling CGT treatments further worsens this. As most therapies are personalized, (using the patient’s own cells), the process is highly dependent on the patient. 

Cell collection is invasive for the patient and should only be undertaken if there is manufacturing capacity to process the cells. Clear communication between supply chain stakeholders helps show availability. But there must also be a way of transporting the cells within the time and condition constraints. 

Even after scheduling, processes are dependent upon the patient’s ability to attend appointments and provide sufficient cell samples. Given how sick many CGT patients are at the point of enrolment/referral, the schedule may change many times and often at short notice. 

Patients are often relying on therapies as a last treatment option. It can take weeks to manufacture a personalized drug so it is vital that the rest of the supply chain moves without delay. With limited slots and appointments available it can be hard for healthcare providers to manage these changes. 

CGT supply chain partners therefore must support patients and healthcare providers by offering flexibility. Providing this flexibility is easier when couriers and the other CGT supply chain stakeholders can share data and collaborate in real-time. 

As transit times can be long and unpredictable, containers being monitored over the journey will generate many data points. Analysing and monitoring these is a task automated, integrated systems are best placed to deal with. Actively monitoring and reacting to data could be the difference between catching an issue in time to preserve cell viability or losing the sample 

For an integrated orchestration platform, CGT courier data is exchanged in real time or at frequent intervals (e.g. five minutes.) This is the human equivalent of an ongoing conversation, or phoning every five minutes for an update. This is clearly not feasible in a manual system but standard in a digital environment. 

Integrated systems also manage data accuracy without the dangers of input errors or the associated hours of labour. When CGT orchestration platforms and shipping portals are integrated, information is gathered quickly and notifications alert to changes or issues. These notifications prompt mitigating actions, and inform relevant stakeholders. 

A cell orchestration system with multiple integrations collates and compiles information form multiple sources to demonstrate chain of identity and chain of custody. It generates alerts and notifications to trigger corrective actions or responses to communicate when key checkpoints are reached. 

With high volumes of data associated with each therapy dose, monitoring and extracting relevant information can be like searching for the proverbial needle in the haystack. But this is where digital systems excel. Automating the flow of information between geographically separated systems and stakeholders, facilitating collaboration, ensuring CGT therapies reach more patients globally. This is going to be ever more critical if the industry is to scale in line with its potential. 

Experienced CGT partners have already embraced the need for these collaborative technology partnerships. More specialists are working together to offer tried and tested integrated supply chain ecosystems to therapy developers worldwide. 

To learn more about CGT supply chain partnerships, read our recent Q&A with Dr Matthew Lakelin of TrakCel and Anton James from Biocair

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