GBI Biomanufacturing’s Plantation plant has wrapped a multimillion dollar expansion that company officials say doubles its stem cell production capacity while adding new clean rooms and bioreactors. The upgrade, reported to cost about $26 million, brings the facility’s footprint to roughly 38,000 square feet and positions the company to supply many more doses to physicians using stem cell treatments. Local biotech leaders say the buildout could help turn South Florida into a larger hub for regenerative medicine if regulators and clinicians line up behind it.
“The state is on the cutting edge of something really significant,” GBI president Jesse McCool told the South Florida Business Journal, arguing the company can scale production while maintaining current good manufacturing practices. McCool and other executives say that scaling could eventually drive down the out of pocket price for patients, but for now most of these procedures remain experimental and are not covered by health insurance.
What the law changed
Florida’s 2025 legislation (SB 1768) creates a limited pathway that allows licensed physicians to use certain non FDA approved stem cell therapies for orthopedics, wound care and pain management, according to the Florida Senate. The bill requires cells to be retrieved, manufactured and stored in FDA registered facilities, while the federal agency’s list of approved cellular and gene therapy products shows the FDA has cleared only a small set of cell products so far.
Oversight and safety questions
Even supporters say the rules only help if somebody enforces them. Priya Chordia, CEO of a stem cell supplier that partners with GBI, told the South Florida Business Journal that regulators need to clarify who will police manufacturing and provider compliance, or noncompliant clinics will have no incentive to stop operating. Public health experts emphasize that contaminated or improperly processed cell products pose real safety risks if oversight is weak, a point no one on either side of the debate is eager to test the hard way.
Scale, jobs and price
Company materials and local reporting say the expansion increases GBI’s stem cell output from a small clinical scale toward industrial capacity, with Refresh Miami reporting that the plant now supports production for roughly 10,000 patients a year and has the potential to scale much higher as new bioreactor technologies come online. GBI currently employs about 60 people and expects to add specialized technicians and engineers as orders grow, according to company and local coverage. Patients should also know that experimental stem cell procedures typically are not covered by insurance and can cost anywhere from a few thousand dollars to tens of thousands per session, as reported by the Orlando Sentinel.
Who’s involved locally
Local firms are already lining up to supply clinics. BioXtek, a Pompano Beach based company led by Dr. Bruce Werber, has been pitching GMP exosome and stem cell manufacturing capacity out of an 11,000 square foot facility, according to a company release on GlobeNewswire. Werber and other clinicians, quoted in the Orlando Sentinel, told reporters that stem cells can reduce inflammation and may help conditions such as arthritis, and that some researchers expect doctor prescribed stem cell therapies to become more routine over the next decade.
Legal implications
The statute establishes patient notice and consent requirements and tells the state medical boards to adopt rules, but it stops short of naming a single enforcement agency, a gap that lawmakers and industry groups will need to close, according to the bill text and committee analyses on the Florida Senate website. That uncertainty is the central regulatory issue as production scales up and more clinics look to get in on the action…