Industry leaders discuss the state of supply chains and clinical trials in the aftermath of the pandemic
COVID-19 disrupted cell and gene therapy trials as well as the contractors and suppliers that support them according to experts.
SARS-CoV-2, the virus that causes COVID-19, impacted all parts of biopharma. For example, the focus on vaccines highlighted manufacturing capacity limitations while increased demand for consumables and raw materials put pressure on suppliers.
The pandemic also disrupted R&D to the extent that some developers put projects on hold according to Amelie Boulais, head of market entry strategy at Sartorius, who told attendees at the BPI virtual conference that the problems fed back up the supply chain.
“The entire supply chain for the industry has been stretched by the pandemic…we try to mitigate any risk of shortages or unanticipated disruptions, we monitor our stock levels during daily operations.
“But all our strategies rely on forecasts from our customers and, with COVID, suddenly, some customers working, for example, in the gene therapy field, just stopped production because the trials were on hold.”
The disruption of supply chains had less of an impact on the cell therapy industry according to Patrick Lucey, CEO of CDMO Lykan Bioscience.
“We actually have avoided a lot of these delays in the cell therapy space. Obviously, the amount of materials we use is reasonably small scale… we're not looking for major demand of excipients, or media components or buffer components or disposables.
“So we've been able to navigate this in a couple of ways. First, you know, our supply chain team was pretty forward looking. So there are common materials across all biologics manufacturers, cleaning materials, and things like this. So we moved quickly and stockpiled a lot of these cleaning materials and things to be prepared for changeover and all that work.
“And then on the on the client or processing material side, again, cell therapy is reasonably small scale, so not a huge demand for common raw materials, we do use a shared raw material approach across clients, so they have a security of supply there.
But the cell therapy sector has not escaped the disruption, according to Lucey, who told delegates clinical trial activities were impacted.
“Where COVID did impact cell therapy is a lot of these therapies in terms of clinical trials require access to ICU for side effects. And certainly at the peak of COVID we saw ICUs in the US and globally overwhelmed with COVID patients.
“So the availability for the proper resources from that perspective, were constrained, and therefore, clinical trials were delayed,” Lucey said.
The positive news is that many trials halted during the early months of the pandemic have resumed. Partly, this is because trial sites have reopened or sponsors have switched to decentralized models. In addition, supply chains have recovered or been modified.
Vectors are an exception according to Lucey, who says that, despite commitments to increase production capacity, sourcing is still a challenge for the cell and gene therapy space.
“The one area that continues to dog the cell and gene therapy segment is really the access to lentiviral, or viral vectors in general. We've seen a lot of capacity go up for viral vector production, but yet we still see some of our clients challenged with sourcing.
“And so that's certainly an area that that's still challenging from a capacity perspective. But otherwise, I think we are we are getting back to normal in the cell therapy side.”
