Artificial recombinant system, without human or animal derived components, and the endotoxin in the products can be controlled at <0.25EU/mL. It has been filed with the FDA DMF, with filing No. of 37790, which greatly reduces the workload and difficulty in submitting the application f or stem cell drugs.
The conventional digestion time is 2 min, and the limit digestion time is up to 15 min, which has solved the problem that the digestion time and digestion strength are difficult to control when the cells are digested by traditional trypsin.
After digestion, there is no need to stop. The product can be obtained by diluting the supernatant of cell culture, which can greatly reduce the use cost.