Kolon Life Science said all of the cells used for manufacturing Invossa – master cell bank, working cell bank, and products – were found to have been GP2-293 cells derived from the kidney, not cartilage-derived cells.
The company recently suspended sales of the arthritis injection treatment after learning that it has been mislabeling a cell ingredient for over a decade.
On Monday, the company announced the results of the cell analysis on Invossa sold in Korea, working cell bank for manufacturing at Wuxi Apptec, and the master cell bank.
“We conducted a Short Tandem Repeat (STR) testing to check whether the transformed cells, the second ingredient of Invossa, were the same from the pre-clinical stage to the commercialized product. We confirmed that TCs had been 293 cells from the preclinical stage to date,” Kolon said in a statement.
GP2-293 cells are abnormal cells transformed for unlimited proliferation like cancer cells.
The company said it delivered the results of the cell analysis to the Ministry of Food and Drug Safety. “We will be working transparently and faithfully to cooperate and make all efforts to relieve the anxiety of patients as soon as possible,” it said.