Wednesday, August 13, 2014

MES for complex biopharmaceutical production implemented in only four months!

World's largest biotech plant for contract manufacturing of recombinant influenza vaccines set up / PAS-X standard software product, fast-track implementation and MBR modeling accelerate MES deployment

The Japanese biotech company UNIGEN Inc. has taken Werum's PAS-X Manufacturing Execution System (MES) into operation within a record time of only four months. The short implementation time was possible because the company relied on a standard solution. PAS-X is operational with all functionalities out of the box.

CST & Werum project managers
at project acceptance
UNIGEN implemented PAS-X using Werum's four-phased fast-track implementation methodology: Ready, Fit, Build and Run. Part of the project and a big success element was the flexible and easy-to-handle PAS-X content and library based MBR modeling.

At the greenfield site in Gifu, Japan, the joint venture of the Japanese pharmaceutical company UMN Pharma and the heavy equipment manufacturer IHI Corporation set up 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 an innovative and complex biopharmaceutical 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 won over several competitor solutions in a multi-stage selection procedure.

PAS-X was delivered with the entire user interface in Japanese. Werum carried out this project in close cooperation with their Japanese integration partner CST Chiyoda System Technologies Corporation. PAS-X considerably reduces the documentation effort for the entire manufacturing process. In addition, the PAS-X functions support warehouse management and automatic workflows based on the underlying SCADA system.

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