With a number of companies now working on rapidly developing treatments and vaccines for the novel coronavirus, the current impact on the pharmaceutical supply chain can be lost.
Prior to the escalation in the number of cases globally, concerns for the supply chain were mainly focused on the availability of active pharmaceutical ingredients (APIs) – a focus that proved to be valid, as shortages were announced.
However, the impact that could be felt on domestic manufacture in relation to complicated nature of the production of cell therapies did not appear as such a concern – until virus cases mounted in both Europe and then the US.
BioPharma-Reporter (BPR) spoke to Christina Yi (CY), chief operations officer at Dendreon, regarding the company’s immunotherapy treatment, Provenge (sipuleucel-T), and how the nature of its time-dependent production is being affected by the virus – as well as how the company is ensuring that patients are still able to receive the treatment.
BPR: What does the manufacturing process for your lead product look like?
CY: Provenge is an active cellular immunotherapy drug, it’s still the only active cellular immunotherapy treatment for advanced prostate cancer. The manufacturing process for the product is incredibly complex, and it's also time sensitive. Essentially, what we do is we take patients’ own blood cells and ship them to one of our manufacturing plants. The transportation to and from our collection centers only has an 18-hour window, as we're shipping live cells. We then ship the cells back in three days.
BPR: How has your overall supply chain been impacted?
CY: When you look at our entire supply chain, every part of it's been impacted, starting from the patient. We're always making sure that the patients are going to be safe – if they have to travel to one of our qualified and approved collection centers, where they get their cells collected. We also have to work with doctors’ offices that are also really impacted by this. They're seeing a decline in people actually coming in.
We also rely heavily on commercial airlines, that's one way we're able to keep our costs down. But as you know, in this environment, the commercial flight airline industry is extremely volatile and unpredictable – so, we don't know if the scheduled flights are going to be operational on the day.
BPR: How do you mitigate these problems?
CY: We rely heavily on Dendreon technical operations team that coordinates all of our logistics for us for the entire company. And they've been working around the clock really since the beginning of March to get the treatments to and from our patients.
The logistics are tough. We have our cell collection centers around the country, which, for Dendreon, are mostly community blood centers. Luckily, they have already safeguarded their locations and their buildings' facilities, so that both their employees and donors coming in can remain safe during this time.
And then, obviously, we have to look after our own employees, which is the first and foremost priority for Dendreon. At our plants, we've limited it to just the essential and critical workforce. We've enforced social distancing, where we can. We've done extra activities, such as stations where you have your hand sanitizers, getting in extra cleaning materials and extra cleaning of our plants.
BPR: How is this adding costs?
CY: Right now, we're operating at a higher cost than we typically do, and yet with no impact to the patient. When they're receiving our drug, they don't receive an additional cost for them to take Provenge. However, the cost for us to transport patients' cells from the patients to our plants can go up to 20-fold higher than what they would typically run to because of the fact that commercial airlines aren't operating as normal. We are now paying for charter flights for one patient's cells to get to and from the plants.
Typically, we would do a drive from our plants that are within a radius of four hours of our two manufacturing plants, in Seal Beach, California, and Union City, Georgia. Now we're extending those out to about 10-hour drives, when we have an overall 18-hour expiry. We're having to find drivers that are willing to take this product, back to the patients or from the patients to us in a very short period of time because we're finding out very late that the flight times that we need are canceled.
BPR: How are other companies working with personalized treatments likely to be impacted?
CY: If you think about Dendreon compared to other immunotherapy companies, I actually believe that they might have even bigger challenges. The cell collection process for a lot of other companies are potentially more academic-based, and those academic-based hospitals are, at this point, managing a number of patients with COVID-19. As a result, they might not be focused on doing cell collections for therapies for people. I think if you have the additional challenges of being just academic-based or having your supply chain in just one area, it's very difficult to continue to be operational and serve patients at this time.
Christina Yi is chief operations officer at Dendreon, where she is responsible for manufacturing, quality, sourcing and procurement, technical operations, apheresis operations and project management.