Challenges in the supply chain which have to be addressed during CAR-T Cell therapy
Currently, once a new medicine was approved, it could rely on the traditional validated environment, while moving to the stage of commercialization. Only the manufacturer set-up for the facility and production took part. As a result, the existing supply chain could be re-used to distribute the medicine through the existing distribution channels. Maybe a little adjustment was needed. And now?
With the new advanced therapies, we face completely new challenges. These challenges greatly affect the integrated supply chain under the aspect of commercialization stage of the cell therapies.
- Cell and Gene Therapies have a distinct business model compared with traditional therapies having a short shelf life, and as a result require complete new production facilities, development of scalable processes and different supply chain logistics
- Requiring an increase of highly skilled labor to scale up autologous manufacturing as current personalized medicine manufacturing technologies require mostly manual labor in opposite to traditional pharma manufacturing
- Evolving manufacturing, process and production characteristics as the process are fine-tuned with new insights
- Evolving ATMP FDA/EU Guidelines (ATMP = Advanced Therapy Medical Products)
- Expensive & labor-intensive processes resulting in high cost of small batch productions resulting in high cost of manual operations and a high cost of QC testing.
Once the appointment with the patient is scheduled and confirmed at the Apheresis centre the planning for following steps will be executed.
The patients T-Cells will be tested, and if passed, they will be shipped to the manufacturing site, while the cells will be kept at predefined temperature.
The manufacturing process will contain the enrichment, activation, transduction and expansion/freezing of the cells. The critical parameters of the intermediate materials are monitored.
Lot release testing serves as the final confirmation of the product quality before release the product for commercial use.
The new cells are then repackaged and will be send back to the patient's hospital or treatment centers, while the cells will be kept at/in the predefined temperature zone.
At the hospital, specially trained staff prepare the cells for infusion into the patients. Perfecting the timing for the last step has proven to be a big concern for the supply chain.
Supply Chain Requirements for personalized medicine
The supply chain must be carefully set up to meet the requirements/challenges since this process is time critical (for some treatments less than 20 days from aphaeresis to re-infusion):
- Improved patient experience by digitilizing the supply chain and information provided to the patient.
- Patient-specific visit scheduling and monitor for infusion extraction.
- Understanding the patient’s material or medication status and the location at any given time. Real-time tracking and controlling with a chain of custody and chain of identity is required.
- How to set up the chain of identity to track down the therapy back to the original donor.
- Manufacturing operation including integration with Level 3 systems, e.g. MES, LIMS
- Accelerated quality control and release based on deviations
- Seamless and Real-Time integration with 3rd party systems. Integration of Cell orchestration Platforms, the patient management system, MES, LIMS, or the courier system to track the position and condition (temperature, humidity etc.) of the patient`s cells to harness data for real-time reporting.
- Financial management to consider the financial requirements for billing, asset management, and human resource considerations.
- Beside detailed scheduling for the required resources, determining the fastest controlled way of transporting the patient’s cells, together with the scheduling of the patient's visits becomes challenging.
- Integrate a solution to automate the process to reduce the manual intervention as much as possible.
The path of advanced therapies like CAR-T and similar personalized treatments present unique challenges to the life science industry. These challenges require a whole new end-to-end capability, from a system, data, process and organizational perspective.
How can Tenthpin help you?
Today, there are no standard processes and solutions available when it comes to cell therapies. Getting the architecture right is key, we can assist you. We do have the insights and technical know-how to make it happen with you. Our consultants all have a unique ‘Tenthpin’ DNA: tech-savvy with a deep understanding of the intricacies of the Life Sciences industry.
We are investing in SAP S/4HANA as a core to our integrated solution for personalized medicine, as we see great potential in SAP S/4HANA and the built-in functionalities, in SAP R/3 or SAP ECC.
Existing Best of Breed solutions are not delivering an End-To-End integrated solution. These solutions will increase the maintenance cost in the long-term, due to the requirement of connecting different solutions.
Contact our industry experts at Tenthpin Management Consultants if you would like to learn more.
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