The MES was implemented at Unigen’s greenfield site in Gifu, Japan, which was built under a joint venture between the Japanese pharma company UMN Pharma and the heavy equipment manufacturer IHI Corporation. The JV has set up one of the largest plants for production of recombinant flu vaccines and contract manufacturing of biopharma products. The plant comprises five floors and accommodates several bioreactors, each with a capacity of 21,000 liters.
At the new plant, Unigen uses a complex biopharma manufacturing process called Baculovirus Expression Vector System (BEVS). For this process, Unigen required a standardized production management software, which is able to meet the high quality and compliance standards in accordance with the Japanese zero-error tolerance. Werum's PAS-X was selected over several competitor tools in a multi-stage selection procedure.
Robert Welter, head of product development at Werum, said, “PAS-X is a functionally complete and scalable MES out of the box, which widely automates actions that previously had to be performed manually.”
PAS-X also considerably reduces the documentation effort for the entire manufacturing process and is used by 17 of the world’s top 30 pharmaceutical and biotech companies in more than 700 installations.
For Unigen, PAS-X was delivered with the entire user interface in Japanese and it was implemented in close cooperation with Werum’s Japanese integration partner CST Chiyoda System Technologies Corporation.
As far as developing trends for MES, Dietmar Mueller, head of sales Asia-Pacific at Werum, said: “The demand is for flexible GMP compliant architectures that can deal with multi-site rollouts covering multiple manufacturing technologies.”