Cellino’s iPSC Manufacturing Tech Receives FDA Advanced Manufacturing Technology (AMT) Designation
With this designation secured, Cellino is looking to accelerate the commercialization of personalized regenerative therapies.
Cellino announced that it has received the FDA’s Advanced Manufacturing Technology (AMT) designation for its induced pluripotent stem cell (iPSC) manufacturing technology.
One of the issues with autologous iPSC manufacturing is that it’s highly complex and requires labor-intensive tasks such as manual passaging and colony picking. It’s pretty specialized, and the number of experts capable seems few and far between, which can create bottlenecks, slow down clinical trials, and increase costs.
In order to address those, Cellino has developed a proprietary bioprocessing technology that they say improves precision, reproducibility, and scalability of the cells.
I’ll be honest, the info on how it works is a little sparse on their website. We’re working on setting up an interview with their team to get more info.
In the meantime, here’s their tech page:
https://cellinobio.com/our-technology
And a webinar they did in 2023:
As you may know, AMT designation is designed to encourage improved manufacturing processes for therapies, and it gives them a few potential benefits that may accelerate their time to market. For instance, they likely now have a foot in the door communication-wise with the FDA, which could help speed up the IND, NDA, and BLA processes, bringing them one step closer to potential commercialization.
This follows their announcement earlier this year, where they launched an iPSC foundry at Mass General:
Really excited to watch them this year… stay tuned.
