Cellular Orchestration Platforms (COPs), such as TrakCel, are designed to improve supply chain performance for cell and gene therapies (CGTs).
This is achieved by:
· Providing full traceability of therapies from donor to recipient – this is especially important for autologous cell therapies, where following modification and expansion at a manufacturing site, starting material derived from a patient must be infused back into the same patient. As the number of therapies being received, processed and shipped by clinical sites, manufacturers and logistics providers grows this will become increasingly challenging.
· Driving compliance with regulations, the trial protocol and Sponsor SOPs at clinical sites, through the implementation of prescriptive 21 CFR Part 11 compliant workflows. Again, as the number of parties involved in cell therapies grows in late stage clinical development and commercialisation, the need for consistency and control increases.
· Capturing Data from multiple parties in the supply chain, giving Sponsors a single-system view of needle-to-needle supply chain performance allowing for analytics and performance optimisation.
· Scheduling of activities in the supply chain to ensure upstream tasks occur only when there is downstream capacity available for subsequent process steps. For example, providing apheresis centres with visibility of manufacturing capacity so starting material is collected only on days when capacity is available for cell modification and expansion.
· Simplifying QA release processes and supporting product quality by providing Quality Staff with all the information on a product’s chain of custody required to certify it is safe for infusion into a patient.
Through the above functionality, COPs can significantly reduce Costs of Goods during clinical development as illustrated below. Savings in this table are based on the following estimated costs for a clinical trial[i] (based on standard pharmaceuticals/biologics – for CGTs, we would expect the cost to be at the high end of this scale, if not higher):
· Phase I $1.4M - $6.6M
· Phase II $7.0M - $19.6M
· Phase III $11.5M – $52.9M
Major cost drivers include clinical procedure costs (15-22%), study administration costs (11-29%) and clinical site monitoring (9-14%). For illustrative purposes, and based on the complexities of CGTs, we will use the higher figure in these ranges for CGTs.
Further supply chain challenges, and associated costs, need to be captured in each therapy’s Cost of Goods (COGs). While a COP may not directly impact on these processes per se, data captured by the system allows Sponsors/Developers to take a holistic view of their supply chain and identify opportunities for optimisation.
· Logistics – COPs can provide logistics providers visibility to future needs, allowing for better forecasting and utilisation of courier services and improved management of specialised shipping system inventories, which in turn can reduce costs. Also, data captured can be used to analyse courier performance, route selection and potential points of failure.
· Manufacturing/QC testing – In many cases, scheduling is performed manually across the supply chain. Automating this process can enhance utilisation of manufacturing assets, which has a significant impact on the cost of goods. Integration with manufacturing equipment allows for a more efficient review of manufacturing data at the time of release.
· QA/QP release – This is a major cost and process bottleneck for even traditional pharmaceutical manufacturers. Capturing data and documentation across the entire supply chain, from multiple sources (as is often the case for CGTs) can be challenging and adds significantly to release timelines – particularly for initial batches. By capturing key data, COPs can help alleviate this – one QP we spoke to quoted up to 40 man hours at a cost of $10,000 to release a first batch of product when compiling data from multiple stakeholders, which can fall by around 85% if all information is available in a single system.
TrakCel’s experience to data has been focused on supporting our clients’ products through clinical development. We are well aware of the challenges ahead when products are commercialised. One client we spoke to when compiling this paper cited that, in order to justify their current market capitalisation, larger autologous CGT developers will need to sell 5-10,000 treatments per year. This in turn equates to 40-60 batches of product released every day. How is this going to be possible using manual traceability and supply chain orchestration? What will the labour cost of achieving this, let alone the risk of product failures in terms of lost material and damaged reputations, amount to? COPs were developed to enable cell therapies to reach their potential – this will not happen without traceability, consistency across all stakeholders, automation and holistic data-driven decision making across the supply chain provided by these systems.