US Food & Drug Administration issues its report of inspection letter to Kimera Labs

Since its inception, Kimera Labs has been dedicated to the production of the purest mesenchymal stem cell (MSC) exosomes in existence. Kimera Labs produces amniotic fluid exosomes and purified MSC exosomes for cosmetic applications and for clinical research. Kimera Labs employs strict quality management protocols that are compliant with good laboratory practices (GLPs) and current good manufacturing practice (CGMP) standards to enable the production of pharmaceutical-grade exosomes for investigational trials and development of future clinical applications.

The US FDA inspected the Kimeral Labs exosome research and production facility in October, 2017. This inspection included a thorough evaluation of Kimera Labs tissue handling, exosome production and purification processes, characterization and quality management procedures. On August 23, 2019, the FDA delivered its establishment inspection report to Kimera Labs indicating a close of its scheduled investigation and inspection.  No Form 483 or other observations were made during the 2017 inspection, and no corrective action was requested or indicated by FDA.

Kimera Labs is engaged in pre-clinical studies for specific clinical applications using pharmaceutical-grade MSC exosomes and adheres to the highest standards of production, purification and characterization of exosomes. Kimera Labs has taken the first steps to gain regulatory review and approval of its investigational trials for specific clinical indications.  It will continue to work closely with the FDA toward the ultimate goal of BLA filing, review and approval for its biopharmaceutical MSC exosome products.