ChondroCelect is the company’s commercial cell therapy product for cartilage repair in the knee.
TiGenix CEO Eduardo Bravo said the EMA has approved the Netherlands facility for the production of ChondroCelect.
"The complexities of manufacturing an advanced therapy medicinal product (ATMP) like ChondroCelect are hard to overstate, and the seamless transfer of these capabilities to a new production facility, while keeping all facets of the process on a par with the original and meeting all requirements of the European regulator are immensely demanding," Bravo added.
"Our production site is unique in Europe as it is 100% geared towards the production of innovative cell therapy products.
"It provides us with crucial manufacturing capabilities to support the anticipated growth in demand for ChondroCelect for cartilage repair, with sufficient capacity for the production of other advanced stem cell therapy products."
The EMA’s approval is related to a Type II variation while ChondroCelect is the first ATMP approved by the agency.