Cellular therapy and all the buzz about it is no mere novelty. The race is on to produce and provide these treatments on a much larger scale, underscored by the nearly $4 billion in potential spending reported by Industrial Info Resources, including the $90 million Orchard Therapeutics plant in Fremont, California. The leap from hospital labs to commercial plants has created a need for solutions and the interest of a wide range of industry suppliers. It has also caught the attention of the U.S. Food and Drug Administration (FDA). Commissioner Scott Gottlieb and Peter Marks, director of the agency's Center for Biologics Evaluation and Research (CBER), while acknowledging the promise of stem cell-based therapies, warned against firms that aren't following the rules. "Some actors are leveraging the widespread belief in the eventual promise of these products, flouting the statutes and our regulations, and deceiving patients by illegally manufacturing or selling purported therapies, and falsely promoting their benefits." In the U.S., thousands of clinics have flown under the radar for years, offering unproven stem cell therapies to patients with little evidence of their safety or efficacy.