26 November 2020 - by Geert Vanhove
About a year and a half ago, we were asked by a client in the US to help them implement capacity planning & detailed scheduling for manufacturing and quality operations in a CAR-T cell & gene therapy production plant. But what are the insights that we have gained since then? And what have we discovered as gamechanging elements in the end-to-end supply chain orchestration?
Every human being consists of cells. Each cell holds genetic material or DNA. Unfortunately, things can go wrong with that DNA. A part can be missing and this is commonly known as a genetic disease. Or certain parts of the DNA might be weak, unable to fight effectively against aggressive diseases like cancer. The basic premise of cell & gene therapy is that it cures diseases by modifying (strengthening) or correcting (cutting & pasting) parts of the patient’s DNA.
To date, there is a limited number of such therapies have been approved, 4 to be precise. But it is expected that, as of 2025, up to 20 new therapies will be approved every year. The first therapy that was launched commercially in 2017 is called Kymriah. Kymriah is a therapy that strengthens the patient’s body so as to allow it to fight more effectively against leukemia.
Kymriah and other cell & gene therapies are considered as very effective for very complex diseases. This is because CGT therapies are very targeted: manufacturers create a unique treatment for each individual patient. However, the fact that these are individualized treatments also means they are costly to produce (=low volume, high value).
Cell & gene therapy supply chains are substantially different from traditional pharmaceutical supply chains, where the most stretched case is autologous therapies that use the patient’s specimen as the raw material for the individualized batch production. This approach requires a fundamentally different supply chain management and operations planning approach.
The need for robust supply chain processes starts in the clinical trial phase, making it an even bigger challenge in a domain where supply chains are still very immature. Phase III CGT trials supply chains cannot simply be managed with Excel and paper.
Looking at the end-to-end process, it consists of different steps that are unique to cell & gene therapies.
1/ Organizing market access
2/ Request for a treatment
3/ The manufacturer has to confirm the request
4/ Specimens are collected
5/ Transported to and from the treatment
7/ Follow-up and after-care
It’s clear that, there are a lot of unpredictable variables linked to each patient batch. And, as the number of treatments and patients is growing rapidly, CGT manufacturers need to make sure there are scalable business processes in place that can handle the high variability in the supply chain: they need to become more agile and have the ability to react in real-time to changing circumstances.
BINOCS is a digital planning & scheduling software for knowledge workers (scientist, lab analysts, …), and we are currently implementing specific modules in our product, in co-creation with some of our customers, to better support CGT manufacturers in dealing with the high variability in the supply chain. The 6 modules in our BINOCS product, specifically for CGT:
1/ End-to-end integration
BINOCS continuously synchronizes with patient journey platforms like Trakcel, Vineti, in-house platforms, … and also as seamlessly integrates with the production shopfloor (LIMS, ERP, AMS, …).
2/ Dynamic site & slot allocation
BINOCS can automatically allocate patient batches to sites & slots, based on configurable assignment rules, optimizing utilization rates.
This process is dynamic (updated & optimized constantly), as Binocs continuously synchronize with patient journey platforms, treatment centers (CRA) and the rest of the supply chain.
3/ Projected slot capacity management
Slot capacity management in Binocs helps you to generate visibility on what you project as available capacity in (slots/day) for patient batches.
This in turn allows you to handle exceptions better (cancellations, non-availabilities, holidays) and optimally utilize backup slots when needed.
4/ Real-time scheduling
BINOCS can automatically create a day-to-day schedule across all teams. And this can be re-shuffled at the click of a button to deal with changes in the planning.
The digital schedule board makes your planning transparent & easy to distribute to your teams.
5/ End-to-end visibility
As we are tracking progress, you get real-time visibility across your different patient batches. You can then zoom in on the status of individual patient batches and ACT.
6/ Operating model management
Incoming patient batches are automatically translated into sequenced and integrated production steps, QC operations, …
This means that it is easily scalable: from scheduling one team to scheduling a multi-site supply chain. Or from handling a couple to a lot of patient batches at once.
A new market
We are looking at a completely new market where demand is exploding, but the supply chains are immature.
Complete mind shift in the way we look at and organize the supply chain. Even if the processes become more robust in the future, there will always be a high level of variability (patient condition, …).
Need to be agile
Companies need to react in real-time, they need to become more agile: immediately capture varieties/events and react to them in real-time.
So, are you eager to find out more about how we can help you in orchestrating cell & gene therapy supply chains? Get in touch and you will find out right away.