Vericel Receives FDA Approval for Advanced Therapy Manufacturing Plant
Thursday, March 05, 2026
Vericel Corporation has received approval from the U.S. Food and Drug Administration to begin commercial manufacturing of MACI at its advanced cell therapy manufacturing plant in Burlington, Massachusetts.
The company stated that the approval allows commercial production of MACI at the new facility to start in the second quarter of 2026. The development is expected to expand Vericel’s manufacturing capacity and support rising demand for its cartilage repair therapy used in sports medicine. The company is also preparing for the potential commercialisation of MACI outside the United States.
MACI is an autologous cultured chondrocyte therapy placed on a porcine collagen membrane and is designed to repair damaged knee cartilage. The product is widely used for the treatment of cartilage injuries, particularly in active patients.
The approval of the Burlington plant marks a key step in strengthening Vericel’s manufacturing network and supply chain. The company indicated that the new plant will support large-scale production of advanced cell therapies while maintaining high quality standards.
Vericel noted that the new manufacturing capability will help the company expand its operations and continue delivering advanced treatment options for patients requiring cartilage repair therapies.
Source: globenewswire.com
