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Re: bkmomail post# 6432

Monday, 01/26/2015 7:00:30 PM

Monday, January 26, 2015 7:00:30 PM

Post# of 27409
I don't think it's very applicable. It would be a liability for CTSO to let hospitals print their own. How would CTSO ensure quality (bead size, pore size, fill weight of beads, etc) and sterility.

Also, 3dp is probably not the best technology to make porous beads, if a printer could even do it. There are a lot of different types of printers, and some do use radical polymerization, but in general, 3dp are very slow and thus, are used for prototyping. The beads are made by suspension polymerization (monomer droplets that form the polymer are dispersed in an immiscible phase to give spherical porous particles). This process is commonly used and very scalable, so not a lot of reason to change.

If you really wanted a more portable way to make beads, it would probably be using microfluidics but you would still have to make FDA ok with it. At this time, I'd really rather not have CTSO spend resources on new manufacturing, but on clinical development.
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