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
Lüneburg, Germany – 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. 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 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.
About Werum IT Solutions
Werum IT Solutions is the internationally leading supplier of manufacturing execution systems (MES) and manufacturing IT solutions for the pharmaceutical and biopharmaceutical industries. Its out-of-the-box software product PAS-X is used by 17 of the world’s top 30 pharmaceutical and biotech companies in more than 700 installations. Founded in 1969, the IT company employs more than 400 people at its headquarters in Lüneburg, Germany, and at nine other locations in Germany, France, Switzerland, the United States, Japan, and Singapore.
Werum is part of Medipak Systems, the Körber Group’s business area pharma systems. Körber is an international technology group that unites about 50 leading companies with over 11,000 employees and an annual turnover of more than 2 billion euro. Under the roof of Medipak Systems Werum provides integrated IT solutions for all phases of pharmaceutical and biopharmaceutical production – from process development through commercial production up to packaging and track trace serialization.
For more information take a look at our website www.pas-x.com.
Director Corporate Communications
Werum IT Solutions GmbH
21337 Lüneburg, Germany
Tel. +49 4131 8900-689
Fax +49 4131 8900-20