The Japanese biotech company Unigen implemented Werum's PAS-X Manufacturing Execution System (MES) in only four months at the company's greenfield site in Gifu, Japan, Werum reported in a press release. Unigen is a joint venture of the Japanese pharmaceutical company UMN Pharma and the heavy equipment manufacturer IHI Corporation. The plant is one of the largest for production of recombinant influenza vaccines and contract manufacturing of biopharmaceutical products that 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. For this process, Unigen required standardized production management software that is able to meet high quality and compliance standards in accordance with the Japanese zero-error tolerance. The short implementation time was possible because the MES program is standardized and was implemented using Werum’s four-phased fast-track implementation methodology: Ready, Fit, Build, and Run. PAS-X was delivered with the entire user interface in Japanese. Werum carried out this project in close cooperation with their Japanese partner, CST Chiyoda System Technologies Corporation.