Elevai manufactures Cell Zero Exosomes™ in a cGMP-based, ISO-certified cleanroom using neonatal umbilical-cord stem cells for maximum purity, potency, and batch-to-batch consistency. The process uses serum-free media, sterile 0.22 µm filtration, continuous QC monitoring, and avoids lyophilization to preserve exosome integrity and biological activity.
This presentation provides a detailed overview of Elevai Skincare's proprietary exosome manufacturing process, a GMP-governed system built to deliver precision, purity, and performance at every step.
At Elevai Skincare, our focus is scientific innovation and excellence in exosome-based skincare. Our in-house manufacturing process provides full control over quality, consistency, and traceability. From cell banking through final formulation, each product reflects our dedication to research integrity, safety, and performance.
All Elevai operations are governed by CGMP-based standard operating procedures. Our integrated manufacturing facility includes research and development and quality control laboratories and an ISO 7 certified cleanroom. Each environment is tightly controlled with HEPA filtration, air pressure differentials, and validated PPE and in-process cleaning procedures. Monthly environmental monitoring ensures a contamination-free processing. Equipment includes liquid nitrogen cell storage, biological safety cabinets, certified CO2 incubators, roller bottles, T-flasks, and sterile filtration systems.
The Elevai manufacturing process follows five validated stages: cell banking, cell expansion, conditioned media production, media harvest and filtration, and formulation and storage. Each step is performed under aseptic conditions to ensure purity, consistency, and safety.
Cell Banking
We begin with human umbilical cord mesenchymal stem cells, or HUMSCs. A master cell bank is created through cryopreservation in liquid nitrogen and prepared under aseptic conditions. Neonatal cells are more potent and consistent than adult stem cells, providing a strong foundation for exosome production.
Cell Expansion
HUMSCs are seeded into flasks or roller bottles using a serum-free, chemically defined media. Cultures are maintained at 37°C and 5% carbon dioxide until approximately 80% confluency. At that point, cells are split or fed to maintain optimal growth conditions for high-yield exosome production.
Conditioned Media Production
During culture, HUMSCs secrete exosomes and growth factors into the surrounding solution, creating conditioned media. This biologically active solution contains nano-sized vesicles and signaling molecules that form the core of our science formulations.
Media Harvest and Filtration
The conditioned media is collected under sterile conditions and filtered through 0.22 µm to remove cellular debris while preserving nano-sized exosomes and soluble biomolecules. The result is a pure, cell-free HUMSC conditioned media ready for formulation.
Quality Control
Each batch is documented and verified through in-process and final quality control testing, including microscopy imaging, hemocytometer counts, and sterility verification. Any deviation or contamination event is escalated and resolved per standard operating procedures, ensuring full traceability, reproducibility, and compliance.
Lyophilization, or freeze-drying, removes water through sublimation at extreme sub-zero temperatures. This process can deform exosome membranes, alter protein structures, and compromise stability and potency. Elevai avoids lyophilization by maintaining liquid-stable formulations, ensuring consistent, ready-to-use products without reconstitution.
Final Formulation
Elevai Cell Zero Exosomes™ are high-potency molecules produced entirely in-house. They are verified via independent third-party analytical testing, free from animal serum and unnecessary additives, and packaged in UV-blocking, airless glass bottles for ambient stability and protection. These measures ensure maximal safety, purity, and efficacy in every product.
Elevai Skincare combines scientific precision, CGMP manufacturing standards, and proprietary exosome technology to deliver reliable, high-performance skincare. Every step of our process, from cell banking to final formulation, reflects our dedication to safety, efficacy, and innovation.