CASE STUDY JAPANESE VACCINES MANUFACTURER UNIGEN IMPLEMENTS PAS-X AT ONE OF THE LARGEST BIOTECH PLANTS IN ONLY FOUR MONTHS

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1 CASE STUDY JAPANESE VACCINES MANUFACTURER UNIGEN IMPLEMENTS PAS-X AT ONE OF THE LARGEST BIOTECH PLANTS IN ONLY FOUR MONTHS Werum s out-of-the-box MES solution supports contract manufacturing of recombinant influenza vaccines in Ikeda, Gifu, Japan AT A GLANCE CHALLENGE CUSTOMER Provide an MES solution that would be able to keep up with the tight implementation schedule and that would allow the definition of production processes from scratch. Meet the high quality and compliance standards in accordance with the Japanese zero-error tolerance. SOLUTION Implementation of Werum s out-of-the-box PAS-X MES solution Flexible MBR modeling based on PAS-X content packages Local support by Werum s Endorsed Service Partner for Japan: CST Chiyoda System Technologies Corporation BENEFITS Fast implementation in only four months Easy-to-handle MBR creation Efficient management of processes and equipment Ensured process and product quality Compliance with regulatory requirements KEY WORDS, a leading Japanese vaccines manufacturer established by the pharmaceutical company UMN Pharma and the equipment manufacturer IHI Corporation INDUSTRY Biotech SITE Ikeda, Gifu, Japan the world s largest biotech plant for the contract manufacturing of recombinant influenza vaccines Manufacturing IT Biotechnology Vaccines MES Out-of-the-box software PAS-X MBR modeling One of the largest biotech plants Compliance Fasttrack implementation Four months Quality by design Paperless manufacturing Operational efficiency Cost-effective production

2 ACCELERATED MES DEPLOYMENT AT UNIGEN S PLANT IN IKEDA, GIFU The Japanese biotech company UNIGEN successfully took 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 on the basis of Werum s four-phase fast-track implementation method: Ready Fit Build Run. The flexible and easy-to-handle PAS-X content and library-based MBR modeling significantly contributed to this success. UNIGEN: A major biotech manufacturer UNIGEN was established in 2010 as a joint venture of the Japanese pharmaceutical company UMN Pharma and the equipment manufacturer IHI Corporation. The company specializes in the production of biopharmaceutical APIs using cellculture technology and has facilities in Yokohama (research & development) and Akita (scale-up). In Ikeda, Gifu, UNIGEN set up one of the world s largest plants for producing recombinant influenza vaccines and for the 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. PAS-X won over competitors 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 production management software which is able to meet the high quality and compliance standards in accordance with the Japanese zero-error tolerance. In a multistage selection procedure Werum s PAS-X won over several competitor solutions. With PAS-X, we found a system that could fit our tight project schedule. Atsushi Ogawa, Director, Project Management, We chose PAS-X for several reasons, says Atsushi Ogawa, Director, Project Management, PAS-X is a standard product which is used by all leading pharma and biotech companies. Together with Werum s services and content packages, the solution exactly offers the flexibility we needed to fulfill our requirements. With PAS-X, we found a system that could also fit our tight project schedule. PAS-X met all requirements with almost no customizations. Marc Bayer, Head of Global Projects III, Werum IT Solutions GmbH

3 PAS-X MES meets all UNIGEN requirements PAS-X met all requirements with almost no customizations, confirmed Marc Bayer, Head of Global Projects III, Werum IT Solutions GmbH, who is in charge of the UNIGEN project. It is a pre-qualified MES enabling UNIGEN to achieve paperless, traceable and flexible operations in a very efficient way. We managed to finish the project within our short time frame, so I think it really was a good decision to choose and implement PAS-X, says Hirotoshi Saito, Unit Leader, Production Department, And Kazuhiro Matsui, Associate, Production Department,, adds: With such a high level of equipment integration, everything needs to work properly, which sets the bar high. But everything was achieved successfully and on time. Flexible and easy-to-handle MBR design Being able to use PAS-X to scale up and define business processes turned out to be a great advantage for a plant that still had to develop the specific production steps necessary for commercial production. Based on Werum s pre-configured content packages and with the help of CST s consulting services, all MBRs were drafted and gradually refined to match the developing processes. Tight project timelines The interdisciplinary team succeeded in finishing the entire set-up of the plant in only 14 months from start of construction of the building to the production of the first engineering batches. The PAS-X MES was implemented in parallel in only four months following the Fit Phase. Editing MBRs via the user interface and by using the flow chart turned out to be very easy and user-friendly. Kazuhiro Matsui, Associate, Production Department, I had no experience with MBR design, says Kazuhiro Matsui, Associate, Production Department, But editing MBRs via the user interface and by using the flow chart turned out to be very easy and user-friendly for our four MBR designers. We managed to finish the project within our short time frame, so I think it really was a good decision to choose and implement PAS-X. Hirotoshi Saito, Unit Leader, Production Department,

4 Japanese user interface PAS-X was delivered with the entire user interface in Japanese a decisive prerequisite for UNIGEN. The system considerably reduces the documentation effort for the entire manufacturing process through efficient electronic, i.e. paperless, batch documentation. In addition, the PAS-X functions support warehouse management and automatic workflows based on the underlying SCADA system. PAS-X is easy to work with and also helps to prevent errors. Kazutoshi Ikeda, Associate, Production Department, It was the first time for me to use an MES. But by gathering PAS-X experience, I realized that you just have to follow the steps offered by the system. PAS-X is easy to work with and also helps to prevent errors, says Kazutoshi Ikeda, Associate, Production Department, Operational efficiency prepared for the future PAS-X enabled us to create a company baseline and helped us to design our production processes, says Atsushi Ogawa, Director, Project Management, With the aid of PAS-X, we could establish a high level of operational efficiency. UNIGEN plans to install two additional main bioreactors and associated facilities at the Ikeda plant to increase the production capacity of influenza vaccines. Considering the flexibility of new MBR creation, we are confident that PAS-X is fit for this system extension, concludes Atsushi Ogawa. With the aid of PAS-X, we could establish a high level of operational efficiency. Atsushi Ogawa, Director, Project Management,

5 PAS-X IN BIOTECH PRODUCTION With PAS-X, Werum provides a complete package that includes software, comprehensive services and pre-configured content for specific biopharmaceutical processes. PAS-X software PAS-X is a mature standard software product which offers high performance and enables fast implementation. The business functions provided by PAS-X out of the box cover all areas related to specification, manufacturing control, quality assurance, and process optimization. PAS-X supports all key manufacturing life cycle stages, such as process development, commercial production and packaging for all biopharmaceutical process types. The functional architecture of PAS-X closely follows the ANSI/ISA 95 standard. PAS-X services With comprehensive services, Werum supports customers during all PAS-X implementation phases: from Ready to Fit and Build to Run. Thus, Werum can take over many tasks which previously had to be accomplished by the customer. In this way, Werum unburdens the customer during MES implementation. The service portfolio is based on the expectations of the PAS-X User Community and on best practices of the biopharmaceutical industry. Werum is able to support customers with many years of biopharmaceutical MES expertise and highly specialized personnel to avoid resource gaps when implementing MES projects. The goal is to ensure knowledge transfer from the very beginning so that the customers can implement PAS-X quickly and, after go-live, operate and manage the system on their own. PAS-X content In addition to supporting consulting services, the pre-configured PAS-X Content Packages allow to jump-start the deployment of PAS-X. They are GMP-compliant, based on the best practices of the biopharmaceutical industry and directed by the PAS-X User Forum PAS X For Us (PFU). The PFU s Special Interest Groups are formed by companies working together to help develop best-in-class MES technology, functionality and services. To set up PAS-X, Werum s industry-specific templates save the customer a lot of time and efforts. When configuring PAS-X, customers no longer need to start from scratch. Instead, they can use pre-built modules. The templates are specifically designed for the biopharmaceutical industry. Together with a Werum consultant, they will be configured to suit the customer s business processes. Teamwork: Successful joint effort through sharing the same goal We would like to thank all partners including Werum IT Solutions, CST and others for their commitment. Our team has a multicultural background but we shared the same goal and approach which was to meet our tight schedule through fast-track implementation of the out-of-the-box solution. This professional environment allowed us to discuss and understand the PAS-X functionality so that we could use as many standard functions as possible. Atsushi Ogawa, Director, Project Management,

6 SUMMARY MES systems such as Werum s PAS-X will become increasingly important as biotech companies face enormous challenges: They are required to improve efficiency and quality, to reduce costs and cycle times and to meet strict regulatory requirements. This also applies to UNIGEN. The Japanese company produces biopharmaceutical APIs and set up a greenfield site in Ikeda, Gifu, Japan, which is one of the largest plants for contract manufacturing of recombinant influenza vaccines. Werum s PAS-X was chosen as the MES for the new plant because it allows a fast-track implementation and flexible MBR creation from scratch. Within a record time of only four months after completing the Fit Phase, PAS-X was delivered to the customer fully tested and with the entire user interface in Japanese. PAS-X now controls an innovative and complex biotechnological manufacturing process called Baculovirus Expression Vector System (BEVS) for the contract manufacturing of influenza vaccines. Thanks to Werum s pre-configured content packages, MBRs could be drafted easily. The project was carried out in cooperation with Werum s Endorsed Service Partner for Japan, CST Chiyoda System Technologies Corporation. ABOUT WERUM IT SOLUTIONS Werum IT Solutions is the world s leading supplier of manufacturing execution systems (MES) and manufacturing IT solutions for the pharmaceutical and biopharmaceutical industries. Its out-of-the-box PAS-X software product is run by 17 of the world s top 30 pharmaceutical and biotech companies and in 800 installations. Werum s manufacturing IT solutions help pharma manufacturers to increase efficiency, improve productivity, and meet regulatory requirements. Headquartered in Lüneburg, Germany, the company is present around the globe. ABOUT UNIGEN UNIGEN was established in 2010 as a joint venture of the Japanese pharmaceutical company UMN Pharma and the equipment manufacturer IHI Corporation. The company focuses on the production of biopharmaceutical APIs using cell culture technology for vaccines by means of the Baculovirus Expression Vector System (BEVS) platform technology. To seamlessly cover and manage the whole process, UNIGEN has facilities in Yokohama (research & development), Akita (scale-up) and Gifu (commercial production). Headquartered in Akita city, UNIGEN employs about 100 people. Werum is part of Medipak Systems, the Pharma Systems business area of the international Körber technology group. Körber unites about 12,000 professionals in about 50 industry-leading companies. Werum IT Solutions GmbH Wulf-Werum-Str Lüneburg Germany T F info@werum.com