GMP Laboratory & Facilities
We established the Class 10,000 cleanrooms according to PIC/S GMP regulation to provide a clean, dust-free, and sterile operating environment for the cultivation of stem cells and manufacture of stem cell-derived exosomes. We adopt FDA-certified instruments and equipment, including a CO2 incubator for cell culture, high-speed refrigerated centrifuge, ultra-low temperature refrigerator, biosafety class II cabinet, high-efficiency lyophilizer, and dynamic cycle UV sterilization ultrapure water preparation system. By using these instruments and equipment we concentrate, extract, and lyophilize stem cell-derived exosomes. The equipment in AM BioTech’s laboratories is 24 hours managed and monitored to ensure the safety and quality of products.
Certified advanced equipment
Set up a 24-hour security maintenance mechanism
Establish a clean room with a cleanliness level of 10,000 for positive pressure cell operation according to PIC/S GMP