News Release
UNIGEN, Japan: MES for complex biopharmaceutical
production implemented in only four months with Werum’s
PAS-X out of the box
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, August 13, 2014 – 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 after completing the Fit Phase. 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 fasttrack 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.
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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.
Photo:

CST and Werum project managers at project acceptance. Source: Werum IT Solutions
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-thebox 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.
Contact:
Dirk Ebbecke
Director Corporate Communications
Werum IT Solutions GmbH
Wulf-Werum-Str. 3
21337 Lüneburg, Germany
Tel. +49 4131 8900-689
Fax +49 4131 8900-20
dirk.ebbecke@werum.com
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