Facility

TissueGen®‘s state-of-the-art facility includes a class 10,000 clean room, manufacturing and testing  facilities to support development and manufacturing of drug-loaded ELUTE® fiber in compliance exact medical standards.

TissueGen manufactures and develops ELUTE fiber in an ISO Class 7 cleanroom environment to support compliance with the Food and Drug Administration’s cGMP regulations for manufacturing drug product.

TissueGen has also implemented an ISO 13485:2003 certified quality management system to ensure quality controls and installed certified HEPA filtration systems to adhere to stringent air quality requirements. This enables development and manufacturing of all ELUTE fibers in support of the same rigorous FDA standards as those applied to pharmaceutical and medical device manufacturers.

Clean Room and Laboratory

Extrusion Facility