Vericel wins FDA approval to manufacture MACI in Burlington

Vericel Corporation said the U.S. Food and Drug Administration has approved commercial manufacturing of MACI at the company’s new, state-of-the-art cell therapy facility in Burlington, Massachusetts, enabling Vericel to begin production in the second quarter of 2026. The action positions the Cambridge-area developer to expand capacity for its restorative cartilage repair product and could support broader commercialization plans beyond the United States.

MACI is described by the company as MACI® (autologous cultured chondrocytes on porcine collagen membrane). Company materials also reproduce the partial indication language captured in regulatory summaries as “indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or ...” The Burlington approval covers commercial manufacture of MACI; Vericel characterized the site as both new and state-of-the-art in its announcement.

“This FDA approval reflects a major achievement for Vericel and underscores the Company’s operational and scientific expertise in complex cell therapy manufacturing,” said Nick Colangelo, President and Chief Executive Officer of Vericel. “Bringing our Burlington facility online for commercial MACI production strengthens our supply chain and supports our mission to deliver innovative, high-quality therapies to patients. We look forward to building on this foundation as we continue to scale our business and create long-term value for patients and shareholders.”

The operational impact includes immediate permission to produce MACI commercially at Burlington with production slated to begin in Q2 2026. Vericel framed the approval as a capacity expansion to meet rising demand for its third-generation cartilage repair therapy and said the facility’s authorization could facilitate potential international commercialization, though the company did not specify any overseas regulatory filings tied to this U.S. action.

Vericel’s manufacturing history provides context for the move. Company and supplier documents note that Vericel has supplied cell therapy products commercially for more than 20 years and secured the first biologics license application approval of any cell therapy product for Carticel in 1997. Its Cambridge facility has manufactured other commercial cell therapies, including Epicel skin grafts for severe burns and Carticel first-generation cartilage repair.

Technical and quality controls at Vericel’s manufacturing operations were described in vendor materials that detail laboratory automation and testing methods used in MACI production. Those documents note use of Thermo Fisher Scientific’s AutoMate Express instrument for automated mycoplasma sample preparation, a total mycoplasma test time of under a day (five to six hours), and an in-house PCR assay that “provides quantitative results in under an hour with a simple workflow.” The vendor papers also report regulatory acceptance of the PCR method for MACI testing by the EMA in 2013 and by the FDA in 2016. Cost figures in the same documents indicate outsourced culture testing can run as high as $1,000 per test while the in-house PCR approach is about $100 per test, a difference that can affect release timing and per-batch costs.

Investors and analysts had been watching Vericel after its late February earnings and guidance update; a market snapshot around the announcement showed the stock trading near $34.96, up about 1.66% intraday. Next steps to watch include the company’s published ramp plan for Burlington, the specific capacity that will come online in Q2, and any filings that would convert the U.S. manufacturing clearance into concrete commercial launches in other jurisdictions.