UNIGEN, a Japanese biopharma company, has implemented Werum’s PAS-X Manufacturing Execution System (MES) into operationwithin four months. UNIGEN implemented PAS-X using Werum’s four-phased fast-track implementation methodology: Ready, Fit, Build and Run, which incorporates flexible PAS-X content and library based MBR modeling.
 
UNIGEN’s Gifu site is one of the largest plants for production of recombinant influenza vaccines and contract manufacturing of biopharmaceutical products. The plant comprises five floors, covering an area of two soccer fields, and accommodates several bioreactors, each with a capacity of 21,000 liters.
 
At the new plant, UNIGEN uses a complex biopharmaceutical manufacturing process called Baculovirus Expression Vector System (BEVS), which required a standardized production management software to meet the high quality and compliance standards.
 
PAS-X is designed to reduce the documentation efforts for the entire manufacturing process and the functions support warehouse management and automatic workflows based on the underlying SCADA system.