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Re: skitahoe post# 367380

Tuesday, 04/06/2021 2:46:59 PM

Tuesday, April 06, 2021 2:46:59 PM

Post# of 717145
ski, the MicroDEN system is basically a shoebox-size incubator that cultures dendritic cells. From what I understand, the EDEN is the fluidic part of the MicroDen device, which has a small polystyrene coated container or cartridge (where the patients’s monocytes are loaded and adhere to) and two bottles, one of which contains a colony stimulating factor (CSF) and other growth medium that continually feeds into the cartridge to grow the dendritic cells, and the other is a waste bottle where the depleted media flows from the cartridge to keep the cells free from waste contaminants. The MicroDEN device contains pumps that keep the fluids in the EDEN system flowing. I believe the device also tracks and logs the patient data through those five steps of the manufacturing process, which will be required for commercial production.

So basically, the patient's monocytes are grown for five days in a growth medium into approximately 25 million dendritic cells, and the dendritic cells are exposed to the tumor lysate, then matured for another half day in a maturation media, then harvested, filled into individual doses (of 2.5 million cells), and then cryofrozen.

Without the EDEN culturing system, the expensive manual process of culturing requires an expensive B-class cleanroom per batch, about 15 hours of labor by highly trained, skilled, and paid technicians who use multiple well plates or T-flasks to gather enough cells for a single patient’s batch, and they have to make multiple interventions to replace the depleted differentiation medium during the almost week-long culturing process, which increases the potential for contamination, and produces inconsistent yields.
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