MIRAMAR, Fla., June 1, 2026 /PRNewswire/ -- Kimera Labs, Inc., a clinical-stage biotechnology company specializing in the research and manufacture of placental mesenchymal stem cell-derived exosomes, today announced the integration of three ISO quality management certifications into its operations. The certifications — ISO 9001:2015, ISO 13485:2016, and ISO 22716:2007 — have been implemented as a unified quality system within the company's 27,000-square-foot facility in Miramar, Florida, and apply across both its investigational manufacturing program and its commercial cosmetic product lines.
Statement from Dr. Duncan Ross, Ph.D., Founder and CEO
"Since 2015, Kimera Labs' quality program has delivered a safe, pure, and highly characterized exosome product. As we develop to act as a manufacturer of placental MSC exosomes for forward manufacturing, as well as our own Phase I/IIa IND approved clinical products, these independent ISO certifications certify our commitment to quality across the clinical, medical device, and cosmetic industries. "
The decision to pursue all three certifications concurrently was driven by the practical demands of operating under a single quality system that governs a broad scope of activities — from IND-regulated manufacturing to GMP-compliant cosmetic production. ISO 9001:2015 establishes the organizational framework for process management and continuous improvement. ISO 13485:2016 addresses the specific requirements applicable to medical device and life sciences manufacturing. ISO 22716:2007 sets the Good Manufacturing Practice standard for the production, control, storage, and distribution of cosmetic products.
Regulatory Background
Kimera Labs holds an active Investigational New Drug application with a Phase I safety trial to be completed by the end of Q3/2026. These ISO certifications extend this compliance infrastructure, providing a documented and independently verifiable quality framework that governs all production activities within the facility, including the manufacture of its Kiara, Luxir, and Vive topical cosmetic product lines.
About Kimera Labs, Inc.
Kimera Labs, Inc. was founded in 2015 and is headquartered in Miramar, Florida. The company operates a 27,000-square-foot research and manufacturing facility dedicated to the characterization, testing, and production of placental MSC-derived exosomes for clinical investigational and topical cosmetic applications.
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SOURCE Kimera Labs Inc
