Planning in any process with interdependent steps required of separate parties is crucial, particularly if the critical delivery path is tightly constrained by timings or conditions. Advanced Therapy Medicinal Product or ATMP supply chain processes very much fit this pattern. With trial or therapy coordinators working with multiple suppliers and healthcare providers distributed globally, and where the patient forms part of the supply chain, there are many complexities that require careful planning for successful delivery.
As vital as it is to plan for success, or the ‘perfect’ path, it is just as important to plan the paths that manage process failures and delays. Many steps in the supply chain are vulnerable to external issues from weather through to global politics and the window for mitigation is narrow.
Material or data in the value chain of an advanced therapy generally relates to live cells in a fresh or cryo-preserved state with prescribed storage conditions and times. So, exception planning must be comprehensive, covering trigger events, key decision makers and information, information flow, corrective action and escalation routes, and most importantly, flag when a therapy becomes unusable. Due to the high cost (both financial and medical) of failure for ATMPs, processes must be robust, with multi-level failover, such as a hierarchy of decision makers or suppliers.
Mapping and analyzing processes in this way not only streamlines the supply chain, facilitates corrective action and reduces product loss and associated cost. It can boost reputation, strengthen supplier relationships, reduce stress levels within the workforce and most importantly, save lives.
ATMP supply partners are limited by the specialist nature of the materials so it’s vital to have known alternatives in case a key supplier becomes restricted. In a regulated industry, these suppliers will likely need to be pre-approved and set up on business systems to ensure the agility to shift quickly.
Building this level of robustness into the supply chain means that processes quickly become complex. But the processes and supporting workflows for ‘exceptions’ are designed to prevent a domino effect where all later steps subsequently fail. These processes consider downstream steps and assess the impact of a delay or change and trigger corrective actions. E.g., if a patient starting sample shipment is delayed, manufacturing slots, final product shipping and infusion dates must be reviewed to ensure that they are still tenable.
The fact that personalized medicine comes in batch sizes of one, creates not only the familiar COI and COC challenges, but vastly increases the amount of data being controlled as a full value chain cycle completes for every patient treated. Additionally, this is not the world of traditional pharma controlling relatively short supply chains from raw materials to bulk dispatch, the personalized medicine journey is not complete until a specific patient has received all the cycles of a treatment that has been produced just for them. This is vein-to-vein supply chain where every step must be planned, monitored, recorded and auditable. The resulting data load has the potential to massively strain the administrative resource managing these therapy journeys, particularly as therapies scale to treat more patients.
The reality is that ATMPs will scale in coming years, there are many trials and approvals in progress, some target rare diseases but many target indications such as solid tumor cancers that affect millions of patients worldwide. As science is breaking boundaries to prove the potential of these treatments, complex supply chains must be managed, or they will become the limiting factor in treating patients.
The good news is that as the CGT industry matures, specialist supply chain partners are growing in experience, and many are working consultatively with clients on process development and collaboratively with peers to support these comprehensive processes. Integration and automation between partner systems aids fast, accurate transfer of data, hence ‘ecosystems’ of connected systems are developing between experienced industry partners. These partners are also adopting a consultative approach, sharing expertise, and working to make data available at detail levels not previously demanded or required.
Cell orchestration solutions (COS) like OCELLOS and OCELLOS Lite from TrakCel are increasingly being acknowledged as the central component of these ecosystems, overseeing and safeguarding critical information, automating complex processes, and sharing data securely to present actionable information to decision makers quickly. TrakCel are also curating and collating the experience gained from in-depth work with multiple, varying clients and supply partners to optimize process flows by bringing both new techniques and tried and tested workflows to the table.
As a second-generation COS, the OCELLOS platform benefits from over 10 years of experience in the CGT industry and as such has been built for connectivity, agile configuration and evolution and deploys in a modular format, making it quick and efficient to replicate best practice processes. And it is a platform that continues to evolve with new integrations and configurations to suit each new process with a view to making revolutionary new medicines accessible to as many patients as possible.
Article by Helen Hopkins - 4 Apr 2022
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