CAR-T therapy is one of the most exciting and fast-developing medicines in the industry today, but as an autologous therapeutic product, what challenges does it pose on designing a patient-centric supply chain to support it? As a key pioneer in the CAR-T space, Kite Pharma had faced the task of developing its supply chain from scratch without having a prior example to follow.
Now, after a series of regulatory approvals for its CAR-T therapy product Yescarta, the company is in the process of expansion. In an interview at Biotech Week Boston, Kite’s director of Global Supply Chain, David Kim, and senior manager of Packaging Engineering, Craig Vermeyen, described the logistical process to Informa Connect’s correspondent Sarah Lintern, reflecting on their first-hand experience.
SL: How do logistics demands differ for CAR-T therapies as opposed to traditional therapies like vaccines or monoclonal antibodies?
CV: The whole supply chain is very different for our current autologous therapies because we’re focused on getting a specific patient’s white blood cells to our manufacturing site and then sending that specific patient’s blood back to them in the form of our oncology therapy, so it’s very specialized and focused on that specific patient. There’s lots of controls in place to make sure we don’t mix up that patient’s cells, and we have a lot more scrutiny on the temperature control and physical integrity of the package, because this is that patient’s only chance at a life-saving therapy.
SL: In what ways has the logistics space responded to complexity of manufacturing these auto products?
DK: To Craig’s point, the number of differences drives the creation of your supply chain process. As Craig had mentioned earlier, the source of your key raw material is also the consumer of your product. The common strategies that one would use on supply chain like warehousing of final product or managing orders months in advance aren’t available - these are very sick patients that you have to respond to, even down to an hourly or minute-by-minute change. You can’t level load your manufacturing or you can’t store any final product because there is no product to store for patients that you could distribute to any other patient. And so all of those complexities related to these differences requires that your supply chain be patient-focused, and centered around the patient, and that the appropriate processes are put in place to support a patient-centric supply chain.
SL: Everyone knows that Kite is one of the pioneers in the CAR-T space, so how did you go about setting up a reliant supply chain when there wasn’t really a precedent for how to do it?
CV: A lot of searching in the marketplace for suppliers that had similar experience. The cord blood industry and other similar therapies that are already-existing has a supply chain, a network that was already set up, so we tailored that to our liking. There was a lot more focus on the chain of custody and the chain of identity, so that’s where I think most of our focus went into building that chain, to ensure we had the patient data and the patient’s material controlled all the way through the process and there’s no chance for a mix-up.
DK: It’s really all about the people. Like you said, there was no precedent to follow, so you’re really trying to figure out how to do it once from end-to-end. And then you have to think about, ‘well, how do I manage a hundred or a thousand patients in any part of the order of life cycle at any one time?’. Any process you develop that falters with the pressure of volume is not a robust process, and so that was part of our challenge. And now where Kite is going is expanding our network, expanding our capability, expanding our market access and our product portfolio, and so all of our growth is through that innovation, really driven by great people like Craig over here.
SL: [Laughs.] That leads me on to my next question. So, when you talk about expanding, how much does being close to major airports like LAX or Schiphol dominate where you set up facilities? Do the airports determine where your facilities are?
CV: The airports themselves, not so much.
DK: If you’re looking at major markets, obviously, being next to any major airport does present its positive effect, as opposed to being hours away from any [nearby] airport. The capability of the airport [is] also clearly important, but after a certain size, the airports pretty much often operate very similarly to each other. The key about managing the airport and infrastructure is really thinking about how you grow in scale to be able to understand what markets you want to access as you continue to expand. For Kite, we have our Los Angeles manufacturing facility that does a good job to support the North American market, but we have opportunities to expand [across] the rest of the world, leveraging those capabilities out of LAX and complementing the strengths and weaknesses of LAX as part of our growth strategy.
SL: Since Yescarta’s approval, you’ve expanded your network of treatment centers. So, how do you manage your cold chain supply?
CV: We’ve scaled up with the same suppliers that we started with in our clinical trials and we’ve helped those suppliers develop themselves into more robust GMP service providers. I think the whole industry is growing in that regard right now because it’s been so new. We are now starting to look at second sourcing suppliers and other risk mitigations to ensure for the future as our volumes continue to grow we have opportunities for new suppliers that may offer benefits that our current suppliers don’t. But up to this point, we’ve been growing together with our suppliers.
DK: And some of the cold chain technologies are reusable technologies, so managing the reverse logistics and the aspect of reusable technology requires that you have to maintain some sort of asset control as well, so we’ve developed processes in place to be able to expand our network in terms of reverse logistics and asset control.
SL: And Craig, you touched on risk, but how do you mitigate against risk?
CV: It’s a big part of our jobs. We have robust risk management procedures at Kite as an organization; our department participates in risk assessments for all new processes. We put together failure mode effects analysis and other process-based risk tools to ensure that we’ve identified the possibilities of risk all the way throughout the process, and then we have a quality system to implement corrective actions, preventative actions, for any deviations or product complaints that we, still, are finding along the way. So I think the risk mitigation strategy goes into every decision we make at Kite.
This interview was filmed as part of BWB TV at Biotech Week Boston in September 2019. Biotech Week Boston 2020 is taking place in Boston, MA on September 21-24, 2020. Find out more here.
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