uBriGene's comprehensive, high-quality facilities fully comply with regulations and ensure product quality. The environment of our GMP cleanrooms are designed to be Grade C + A, with our centrifugation, culture and aseptic filling processes completely carried out inside aseptic isolators. This design guarantees a Grade A production environment while effectively controlling costs. Our facilities allow cell and gene therapy companies to complete IND applications and achieve commercial production with time and cost efficiency.
uBriGene has two main production facilities located in Jinan and Suzhou.
The Suzhou production facility is located in Suzhou Biobay Biomedical Industrial Park, with a facility area of 9,000 square meters. It contains four plasmid production lines including three with a fermentation scale of 10L and one with a fermentation scale of 50-200L, as well as six viral vector production lines including three with a fermentation scale of 50-200L, one with a fermentation scale of 500L, and two single-use only lines with a fermentation scale of 2000L.
The Jinan production facility is located in Jinan Pharmaceutical Valley Industrial Park, with a facility area of 5,000 square meters. It contains two plasmid production lines, three viral vector production lines, and six cell therapy production lines.
The production areas, quality control areas and storage areas are completely physically separated and each production line in the production area has independent air-conditioning systems.
Plasmid Production Suites
The plasmid production suites are designed with four functional areas for medium preparation, fermentation, purification, and filling, respectively, as well as supporting auxiliary functional areas. Medium preparation, fermentation and purification are performed under Grade C standards, and the filling room is designed with a Grade A aseptic isolator.
Viral Vector Preparation Suites
The viral vector preparation suites are designed with three functional areas for fermentation, purification, and filling, respectively, as well as supporting auxiliary functional areas. Medium preparation, fermentation and purification are performed under Grade C standards, and the filling room is designed with a Grade A aseptic isolator.
Cell Preparation Suites
The cell preparation suites adopt a fully enclosed Grade A design with a Grade C background environment. All the production process equipment are single-use only, packaged aseptically, and integrated into sterile isolators. To ensure sterility and safety, the materials used in one batch are sterilized and transferred into the aseptic isolator production line together, and the entire operation proceeds inside the isolator.