December 6, 2022
Cell and gene therapy firms still face a “capacity crunch” – a lack of manufacturing space, technology, or raw materials that delay projects – according to experts, who say disruption caused by COVID-19 and the surge in R&D as the pandemic ebbs have made the situation worse.
In 2017, the New York Times suggested a lack global capacity for the production of viral vectors was slowing the development of cell and gene therapies. The thrust of the article was that production methods took too long, and that not enough suppliers had the skills to undertake such work.
Since then, concerns about the so-called “capacity crunch” have expanded – particularly since the pandemic – with observers pointing to other issues like the lack of bioreactor capacity for commercial scale production as another major challenge.
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And such concerns remain, said Kelly O’Hare, senior vice president of operations at Lykan Biosciences. She told delegates at the Cell and Gene Therapy Manufacturing and Commercialization conference in September the large number of therapies in development is a challenge.
“In this space, specifically, there are such a large number of drugs in development in early stage. And so I think the capacity crunch is clearly right now in early stage first IND, first out into human. At some point that will expand to the commercial space when more of these drugs get approved.”
O’Hare also suggested developers are still mulling whether to keep production in house, explaining: “There’s always a lot of this build versus buy decision making. And I think companies just aren’t really quite sure where they are, where they stand with that yet.”
Fellow panelist Brian Taylor, executive vice president for biopharma solutions at Smart labs, agreed that the capacity crunch was real and ongoing, telling delegates that the lack of cell and gene therapy production skills in the contract development and manufacturing organization (CDMO) space was another constraint.
“I think that there was definitely capacity crunch. I think it is actually probably worse for the cell and gene therapies just because it was so much more nuanced in the manufacturing process. And so because of that there were fewer players that knew how to do it.”
And while there has been some improvement, cell and gene therapy developers would benefit from more contractors with expertise according to Taylor.
“I think it continues to be a problem for all of us. I think that it was definitely a problem, even with monoclonal antibodies, where it was a known process that we all knew what we were doing. And even then, we had capacity issues. So I don’t think I talked to anybody in the industry that didn’t look at it at month lead time just to get capacity at the CDMO. And that’s been that way for last 10 years, at least.”
The pandemic exacerbated the problem according to Kumar Dhanasekharan, SVP of technical operations at Renovacor, who said COVID-19-related disruption to the materials supply chains affected project timings.
“What we noticed in the pandemic – because you couldn’t get some of the raw materials needed for manufacturing – the CDMOs actually had capacity at the last minute, because none of their clients could, you know, really get their materials in time.
“And so that only made the situation worse, because everybody then pushed out, let’s say a few months, and now suddenly, there is more demand than supply in that next window of 18 months, making it even worse for new clients to come into this CDMO space.”
Larry Lockwood, vice president of sales at bioscience raw materials supplier Aldevron also cited COVID-19 related disruption as an exacerbating factor.
“So without a doubt, there was a capacity crunch pre pandemic and throughout the pandemic, for sure. From our perspective, we had to find ways to address that by improving technology, etc and adapting some continuous improvement methods.
“Also, I think that we really struggled with the raw materials and the supply chain. As we got capacity in the facility, we continue to run into simple things like you couldn’t get vials to do the final filling.”
And these capacity constraints are not likely to ease any time soon according to Lykan’s O’Hare, who said an increase in demand as the pandemic ebbs has introduced new pressures.
“I think what we’re seeing now is a surge, right. So there’s a surge in demand for capacity because everyone is restarting trials; everyone is coming out of some of their supply shortages. But what we’re really seeing in supply chain is the story has not ended.
“There are still significant constraints in supply, primarily in some of the primary equipment like incubators, in some of the primary materials like cell stacks. And so the industry has not caught up yet. And it’s been a bit of a challenge to help folks get their production scheduled, when we’re still seeing the supply chain issues.”
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