A delegation of the Ministry of Food and Drug Safety left for the U.S. on Sunday for a weeklong inspection of Kolon TissueGene to check how the cell ingredient of osteoarthritis gene therapy Invossa-K was mislabeled. The delegation is scheduled to return to Korea on next Sunday.
The regulator dispatched more than 10 officials as the inspection team, about five times the average size of an inspection delegation. The inspection on Kolon TissueGene, a subsidiary of Kolon Life Science, began on Monday.
The inspectors will visit Invossa developer Kolon TissueGene, cell line manufacturer Wuxi Apptec, and Thermo Fisher Scientific where cell bank is stored, to identify how the cell ingredient was changed.
The ministry is analyzing the master cell bank owned by Kolon TissueGene, as well as testing polymerase chain reaction (PCR) to detect a gene (gag•pol), which exists only in the kidney-derived cells. Also, the ministry is checking if the cells in the second fluid of Invossa are multiplicative even after radiations.
The ministry said it would decide on an administrative measure against Kolon Life Science by reviewing the results of the inspection this week, together with test results on Invossa and the outcome of the March 2017 test that Kolon TissueGene had noticed a problem in the drug ingredient.