My thoughts.... Upon receipt of the vials they will thaw and grow them to I’m guessing 7-10L batch - perform the encapsulation reaction (longest reaction step I’ve seen is 24 hours) allow the cells to grow for a known amount of time to fill the ciab, then take samples for mycoplasma and sterility. They can then fill syringes and lyophilize (freeze dry) the product in parallel to that testing. The functional testing they talked about I’m guessing is taking sample syringes and testing that they work properly after freeze drying and maybe testing the syringe packaging integrity. Then if all passes file ind and ship to PMCB for trial prep. Jmo.
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