1. Raw material feeding and pretreatment (GTP starting point)
Clean area (Class D/C) : Sterile operating space that complies with GTP specifications
Raw material receiving and storage equipment : Refrigerator/freezer (2–8°C, -20°C, -80°C), liquid nitrogen storage tank (-196°C) depending on the nature of the raw materials
Aseptic operation table (BSC Class II) : for initial processing and packaging
Automated tracking system : barcode/QR code labels are integrated with LIMS system to ensure source traceability
2. Stem Cell Culture and Exosome Production
Cell culture incubator (CO₂ incubator) : Control temperature, humidity and gas concentration
Cell culture consumables : T-flask, spinner flask, bioreactor
(such as Wave or swing reactor)
Cell separation and purification equipment :
- Centrifuge (high speed/low speed)
- TFF (Tangential Flow Filtration) system: exosome purification and concentration
- Magnetic bead sorting system (such as MACS): cell subpopulation separation
AI-based parameter optimization platform : AI next-generation automated cell production, optimizing culture conditions and quality control through AI models
3. Quality Control (QA/QC)
Cell and exosome detection equipment :
- Flow cytometer
- NTA (Nanoparticle Tracking Analysis) Exosome Particle Size and Concentration Analysis
- ELISA, qPCR, Western blot: protein and gene expression analysis
Sterility and endotoxin testing system : LAL test, Mycoplasma test
Document and batch record system : electronic record system in accordance with ISO 13485 and PIC/S GMP requirements
4. Product Grading and Storage
Packaging and packaging equipment :
- Aseptic filling system (can be integrated into Isolator or Open-RABS)
- Automatic plugging/capping system
Freezer and Refrigerator Storage Equipment :
- -20°C/-80°C Freezer: Short-term storage
- Liquid nitrogen tank (-196°C): long-term storage
- Cold chain monitoring system: temperature recording and alarm
5. Classification and shipment
Product classification and labeling system : According to the content of regeneration factors, application areas
(such as bone repair, nerve repair) classification.
Packaging and logistics :
- Cold chain packaging materials (dry ice, cooler boxes)
- Shipment tracking system integrated with COA (Certificate of Analysis)