The lifesaving potential from cell and gene therapy is a rapidly evolving space and consequentially so are the supporting supply chains. The supply chain processes for personalized therapies begins with an error free tailored supply chain for each gene and cell therapy patient.
There are various cell therapies in development, but an approved therapy and the one leveraged as an example here is CAR-T. The typical process for a CAR-T cell therapy begins when the patient gives a sample of their blood at an Apheresis Clinic. Cells are then separated from the blood and shipped the manufacturing site using transportation partners. Based on the stability data, manufacturing sites have 48-96 hours after receiving the cells to process the order.
Accurate tracking and traceability are critical in managing the gene and cell therapy supply chain. The correct patient needs to be given the correct dose at the correct time thereby, making the entire process contingent on the accuracy of patient information and tracking of the material. There are several un-controllable variables in this process, primarily relating to cell count pre-conditions, impacting the ability to manufacture. Which is why the variables that can be controlled must be managed well.
Life Sciences companies looking to consolidate their gene and cell therapy processes into their central SAP S/4HANA (or even ECC) ERP platform require a robust solution to service these needs and leverage existing capabilities. Clarkston’s SAP-based CTOP Platform (Gene and Cell Therapy Orchestration Platform) combines deep Life Sciences Industry and SAP expertise to provide that very solution.
Given the complexities in this process, it is critical to have an integrated and collaborative network connecting all relevant stakeholders. Clarkston’s CTOP approach leverages proven core SAP functions around patient scheduling, such as PPDS (Production Planning & Detailed Scheduling) to drive this process, which can impact schedules for stakeholders in the process such as transportation and manufacturing schedules. The PPDS solution is layered with an enhanced scheduling engine, which is then connected with external facing applications. These apps act as a portal or a hub which integrates with all the clients partners/service providers such as apheresis sites, transportation providers, and manufacturing.
Maintaining the integrity of this process will also require strict documentation of the Chain of Identity and Chain of Custody. Clarkston’s CTOP solution leverages the SAP S/4HANA’s Cloud Platform as a base for our core solution, integration with third-party systems and serves as the data repository for COI and COC Data. COC and COI is at the core of Clarkston’s CTOP solution and every interaction of treatment from needle to needle or cell to cell is captured in CTOP for the reporting and audit purposes.
Clarkston’s CTOP Solution provides the platform to manage integrated and collaborative communication and visibility with all the stakeholders (e.g. Clinical Sites, Couriers, Apheresis Clinics). Dashboard style interactive reporting, drill down capabilities to the information at the stakeholder level based on their business functions. Clarkston CTOP Solution can be leveraged by a Cell Therapy Sponsor, Clinic, or CMO to manage their operations and provide a holistic view across their entire cell-therapy therapy product lines. Some of the key macro business process areas, which can be managed by CTOP are Patient Enrollment, Patient Apheresis Appointment Scheduling, In-bound Transit, Cell-Collection Processing, Manufacturing Updates, Outbound Transit and Treatment Infusion Scheduling.
The purpose of the CTOP is to integrate the overall processes for cell and gene therapy into a single platform. Consolidation of all services required provides better documentation, reporting and ease of access for users at all levels of the supply chain.
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Contributions by Sapan Desai and Eshan Kalarikkal.