Experts predict that allogeneic cell therapies will grow in 2022 and beyond thanks to a market that's more than ready for them.
Not only do these products stand to help more people, but they also represent a supply chain that's potentially less complex. While you can expand an allogeneic product from healthy donors to patients with relative ease, autologous therapies have the central challenge of having to work with cells taken from very sick people. These and other complexities have pushed researchers to explore allogeneic approaches for procedures such as CAR-T immunotherapy.
But at the same time, allogeneic cell therapies require a much more comprehensive scale-up strategy. You need to consider not only your desired yield (which may be a lot for a one-to-many therapy) but also how labor, cost-of-goods sold (COGS), space, and timeline pressures may impact plans to reproducibly expand cells for master cell banks, working cell banks, and ultimately the product itself.
In addition, if you're working with attachment-dependent cultures for those therapies, cell processing can be even more challenging. While bioreactor technologies like microcarriers exist for adherent cells, they're not considered a perfect match because the microcarriers need to be taken out of the therapy before it goes to patients.
Waisman Biomanufacturing, like so many others in the industry, experienced these pain points as it looked to expand capacity for a portfolio of human embryonic stem cell banks, mesenchymal stromal cells, and other cell lines. Not wanting to undergo significant renovations or a hiring spree, the organization reached for a low-maintenance stacked system that exponentially grew its cubic footprint.
Did it work? With a 250% jump in production power and only a modest 20-25% bump in costs, it's safe to say it did.