Merck MES Upgrade to Werum s PAS-X V3 live at one of its largest plants

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1 Merck MES Upgrade to Werum s PAS-X V3 live at one of its largest plants Go-Live at plant in West Point, PA, USA / Additional PAS-X rollouts in the U.S. and China are on the way As part of its global MES rollout program, Merck Sharp & Dohme Corp., a subsidiary of the global healthcare company Merck, has successfully launched its standard MES system at its production site in West Point, USA. West Point is one of Merck s largest pharmaceutical and vaccine manufacturing plants producing a variety of products helping the world to be well. The Merck MES system is based on PAS-X Version 3, the newest offering of Werum s PAS-X Manufacturing IT Business Platform. PAS-X is a software solution that provides an extremely high level of standard functionality for the pharmaceutical sector out of the box. CONTENTS Merck: PAS-X upgrade at one of its largest plants p. 1 McNeil: Go-Live in Puerto Rico p. 1 Bayer HealthCare: Go-Live in Myerstown, USA p. 2 Merck Serono: On the Way to an Integrated Biopharmaceutical e-plant p. 2 Novartis: Go-Live of PAS-X Process Development p. 3 B. Braun: PAS-X Information Nucleus in Irvine, USA p. 3 PAS-X Interview: The Manufacturing IT Business Platform for Level 3 p. 4 PAS-X Feature Packages: Examples Process Development and Track & Trace p. 5 AstraZeneca: Combined PAS-X/SAP rollout at one of the largest tablet manufacturing plants p. 6 Novo Nordisk: PAS-X becomes central Manufacturing IT platform p. 6 Werum and Glatt develop first industry-specific MBR Libraries p. 7 PAS-X Manufacturing IT Business Platform p. 8 We re very satisfied with the recent deployment of MES at West Point, said George Llado, Merck s Vice President, Merck Manufacturing Division IT. Werum delivered the PAS-X package on-time and within budget, providing exceptional support post go-live. MES is a mission critical productivity platform PAS-X Go-Live at McNeil in Puerto Rico, a Johnson & Johnson co. The pharmaceuticals manufacturer McNeil is in the process of deploying Werum s MES PAS-X at its plants in Las Piedras (Puerto Rico) and Fort Washington, PA, USA. The key objectives are to convert paper-based batch records into electronic ones to enhance compliance by reducing the opportunity for human errors, among other benefits. PAS-X for weighing and dispense functionalities is in operation in Las Piedras, one of the world s largest production Merck Sharp & Dohme produces a variety of vaccines. for the Company. Having a trusted supplier in Werum working very closely with our business and IT teams was essential to project success. The pharmaceutical company is running an MES program around the globe through 2015 as part of its rollout plan. Already in the implementation phase: the Merck (known as MSD outside the United States and Canada) plants in Wilson, North Carolina, USA, and Hangzhou, China. sites for solids manufacturing. A second phase is scheduled where PAS-X will be installed across the various manufacturing and packaging areas in an iterative manner. Simultaneously, PAS-X will be deployed by phases in the Fort Washington site and will act as the level 3 platform between SAP and the highly automated production equipment. Since project start, McNeil has approached system design to facilitate future deployments within the supply chain.

2 SUCCESS STORIES PAS-X Goes Live at Bayer HealthCare, Myerstown, USA Bayer HealthCare Solids production facility at Bayer HealthCare. The Go-Live of the Bayer HealthCare MES Core 2 system in Myerstown, PA marked an important milestone for the development of the MES Core system for Bayer HealthCare. Myerstown is the first Bayer HealthCare production facility on the deployment roadmap to start operations with the enhanced BHC MES Core 2 system. The system is based on the latest IT landscape with a cluster and Citrix environment and it also integrates with the central BHC SAP ERP system. The installation represents a fullblown MES system for about 250 concurrent users with a complex automatic Weighing & Dispensing system and an underlying weighing system by AZO for the manufacturing of vitamin tablets. In the next step Performance Management will be rolled out for Overall Equipment Efficiency (OEE) functions to the site (the so-called Production Control Center). With this successful first rollout of the BHC MES Core 2 system, Bayer HealthCare has accomplished another important step in implementing our global MES program, says Dr. Till Hagemann, Manager BHC Global MES Program. Now, we are looking forward to continuing the rollout at the other sites on the BHC Core Rollout Roadmap. With PAS-X on the Way to an Integrated Biopharmaceutical e-plant Go-Live of Werum s PAS-X at Merck Serono in Vevey, Switzerland / Efficient Data Flows from Process Development to Commercial Production PAS-X successfully went live at Merck Serono s production plant in Vevey, Switzerland. Werum s worldwide Merck KGaA The oncology drug Erbitux is produced in Vevey, Switzerland. leading Manufacturing Execution System for the pharmaceuticals and biotechnology industry manages and controls the manufacturing of the cancer treatment drug Erbitux, which Merck Serono produces at this site. As the central IT platform, PAS-X integrates the ERP and two DCS systems, replaces paper-based documentation and ensures efficient, seamless batch and process data flows from process development to commercial production. As a result, Merck Serono has moved a giant step closer to achieving its goal of setting up an integrated biopharmaceutical electronic plant at Vevey. Our biopharmaceutical production benefits considerably from Werum s PAS-X MES, said Nicolas-Martin Clément, e-plant Manager at Merck Serono. The number of data entry errors has greatly decreased, and with the review-byexception function we can approve manufacturing records in half the original time. For us, that means a great reduction in the non-value added activities! Against the background of this positive experience, Werum has begun with the implementation of PAS-X for another new production system in Vevey for Rebif, a drug for treatment of multiple sclerosis. As part of the project, Werum will connect the PAS-X system to the LIMS system and support the perfusion process with new MES functionalities. In the context of its global MES partnership with Merck Serono, Werum has equipped three production sites with PAS-X up until now: the biotechnology plant in Vevey as well as the pharmaceutical plants in Darmstadt, Germany and Naucalpan, Mexico. 2

3 SUCCESS STORIES Go-Live of PAS-X Process Development at Novartis Pharma AG Efficiency gains through simplified Process Development oriented recipe modeling at Novartis sites in Basel and Stein Novartis AG, Mathias Leeman Novartis headquarters in Basel, Switzerland. The global pharmaceutical company Novartis is relying on Werum s PAS-X Process Development Feature Package to develop pharmaceutical manufacturing processes and produce clinical batches at their Swiss GMP pilot plants in Basel and Stein. Novartis can use recipe library elements and machine master data that are preconfigured in the PAS-X installation for this purpose and thus benefit from simplified and faster process modeling as part of their production studies. Further advantages in terms of flexibility can be gained by using the just recording mode offering fully flexibility for technical batches for development but at the same time ensuring collection of all GMP relevant data such as material consumption and equipment usage. Werum s PAS-X Process Development Feature Package replaces a paper based legacy. PAS-X provides standardized interfaces to SAP, which were also implemented during the project. Novartis and its associated companies have been using Werum s PAS-X already for a long time as a standard Manufacturing Execution System in commercial production, commented Ruth Leu Marseiler, business project lead for the introduction of PAS-X from Novartis Pharma. Based on the good PAS-X experience we had in the past we decided to use PAS-X Process Development that is part of Werum s Manufacturing IT Business Platform as well. Werum developed the PAS-X Process Development package in close cooperation with Novartis and other pharma companies as part of the activities of the PAS-X for Us (PFU) User Forum. PAS-X Information Nucleus at B. Braun Irvine, USA B. Braun s facility in Irvine, CA is currently installing a new, highly automated production line, with PAS-X as a core component. The line, designed to produce a variety of IV solution bags for hospitals and clinics, will manufacture the empty bags, fill them, sterilize them, and package them, all under full automation. To achieve such a sophisticated approach, B. Braun has defined a multi-level IT architecture that links ERP to PAS-X to the equipment controllers. PAS-X plays a key role for us, explains Imran Rauf, the Engineering Manager for the project. The MES is our main link to the overall order and inventory data controlled by the ERP, triggers the correct recipe execution at the equipment level, and consolidates all of the key production data into our final electronic Batch Record. The most unique feature of this project was the high level of integration between PAS-X and a large number of equipment types, resulting in PAS-X supporting 25 different message types. The expected benefits to B. Braun of this architecture is streamlined batch production execution, final batch review, and product release. Additionally, the captured process data will be used for ongoing process improvement. This highly integrated approach has already been proven in the LIFE and LIFE Nutrition sites at B. Braun in Melsungen, Germany. PAS-X supports the production of IV solution bags. PAS-X fulfills the specific needs for our global biotech and pharma production. Werum has always demonstrated in our global MES implementation projects their strong leadership in MES solutions for the life science industry, especially by their professionalism in handling global projects and the overall system support. Based on the overall successful Go-Lives in various countries, it is now our challenge to have an effective and optimized Review by Exception process realized. MES is always a long term journey and we are optimistic for having more production sites using PAS-X. Dr. Jörg Spörle Senior Vice President, Pharma Manufacturing Global Market, Technical Operations Merck Serono 3

4 PAS-X PRODUCT NEWS PAS-X is a standardized Manufacturing IT Business Platform for Level 3 Interview with Hans-Peter Subel, Werum Software & Systems AG on Werum s current strategy, new functions and future developments of PAS-X What are the future challenges for the pharmaceutical industry in the area of Manufacturing IT? Subel: The pharmaceutical industry is changing faster every year, so it s extremely important to keep up with new technologies and trends. The industry needs to refresh its business processes and IT architectures. The demand is for flexible GMP compliant architectures that can deal with multi-site rollouts covering multiple manufacturing technologies. Pharmaceutical companies must align business and production processes with the objective of site-wide Operational Excellence. For all this, flexibility and agility is the key. In which ways does Werum s PAS-X Manufacturing IT Business Platform support the pharmaceutical industry? Subel: PAS-X is no longer purely a Manufacturing Execution System, but rather a standardized Manufacturing IT Business Platform for Level 3. From Process Development to Clinical Trial Manufacturing to Commercial Production and Packaging our Manufacturing IT expertise gained in over 600 installations covers all types of manufacturing in the pharmaceutical industry. This includes solids and liquids, blood plasma derivatives, biopharmaceutical products and active pharmaceutical ingredients. And, most recently, we are implementing PAS-X at a company making customer-specific therapies, a field seen as the future of drug therapy. We have reengineered the architecture of PAS-X to simplify software maintenance. As a result, product updates can be carried out at lower cost. Software updates in the GMP environment are traditionally difficult, as they entail a great deal of testing and strict validation requirements. We have successfully addressed this challenge with our current software architecture. We also provide a full services package to assure compliance is achieved during implementation. What new functions can users expect in the near future? Subel: One exciting new feature is simplified MBR simulation. Complex processes can be simulated and tested prior to use much more easily than before. Users can create executable EBRs and generic MBRs with a mouse click. The MBR Designer also offers faster navigation, making it possible to jump to specific basic functions in order to test dedicated parts of a recipe. We have also improved the external view of MES data, which we have developed together with the PFU, the PAS-X user community. Data from production can be easily queried and viewed. With better access to this data, processes can be analyzed and the performance improved. The structure of PAS-X data has been enhanced to make it easier to display in reports and charts, especially in OSIsoft products or other 3rd party statistical analysis tools commonly used by our customers. Additional new functions include the more versatile management of shop floor orders, the setting of time stamps for the equipment status, expanded functions for recipe management and simplified correction options for already executed EBRs. How do the new MBR templates simplify the manufacturing of drugs? Subel: Using our MBR templates, electronic MBRs can now be created within a rather short period time. The Werum templates provide standard pharmaceutical manufacturing business processes that can be used as a starting point for MBR design. The MBR templates are like Word or Excel templates. This construction kit for MBR creation is supplied in the system libraries and will speed up the MBR creation process. Has the industry s experience been integrated in the development of the templates? Hans-Peter Subel, Member of Executive Board, Werum Software & Systems AG Subel: Yes, it certainly has. The templates are based on best practice examples from the pharmaceutical industry, and we have developed them together with the PFU. The focus is currently on the creation of templates for biopharmaceutical and liquids production. We expect to add packaging processes in the near future. In addition, we are intensively cooperating with partners from the industry, for example with the pharmaceutical equipment provider Glatt. In the future, customers who purchase a machine from Glatt will also be provided with templates for granulation or coating that can be easily plugged into PAS-X recipes. 4

5 PAS-X PRODUCT NEWS What are the benefits of an upgrade to PAS-X V3? Subel: It is worth upgrading to PAS-X V3 because customers can take advantage of our newest technology that offers simplified approaches to updates and can extend running systems with Feature Packages. Secondly, you get all new, powerful V3 MBR & EBR functionalities that will increase operational efficiency, like the graphical MBR Designer, generic MBRs, MBR libraries including parameters and adapter-based PCS/Level 2 integration. You can also leverage upcoming features, like MBR simulation. And the new architecture makes incorporating product-specific enhancements to the newer version much easier and cheaper to implement and maintain. We are working with Werum since many years at the heart of our biotech production. We eagerly anticipate the Go-Live of the new version of PAS-X in our packaging area to see whether it can support us with the new flexibility challenges coming in the future. Dr. Bernd Lehle Director Biopharma Electronic Management Systems Boehringer Ingelheim PAS-X Feature Packages Feature Packages are optional add-ons for the PAS-X standard system that have their own versioning, but link seamlessly into the product modules. Depending on the requirements, customers can begin with Feature Package based functionalities alone, and extend this to a full MES later on. This approach also enables the flexibility of extending PAS-X using Feature Packages after an initial MES implementation. Examples for Feature Packages are Process Development and Track & Trace: How will PAS-X continue to develop in the future? Subel: We will provide stronger support for a central data center model, which would offer PAS-X ondemand to various production sites. The scalability of the systems is about to increase, providing more flexibility for increased users, processes and fields of applications. And, apart from our software and architecture improvements, we will extend our services to incorporate higher level project consulting, more extensive, global on-site services enabling turnkey projects. Finally, PAS-X will improve its mobile platform support. We are currently enhancing the software for mobile devices. Regardless of whether it s a smartphone, tablet, PDA or notebook the system interface will be optimized for that form-factor and features like gesture control will also be supported. This enhances Werum s role-based user interface approach by offering each system user the most appropriate interface. Process Development The PAS-X Feature Package Process Development simplifies modelling of technical and clinical manufacturing processes. This Feature Package closes the gap between research & development and batch-based commercial production. It covers process development in all areas of the pharmaceutical industry, including scale-up. During the scale-up, i.e. when transferring production processes from the laboratory to industrial scale, it is imperative that no information is lost and successful technology transfer is ensured. The Feature Package offers suitable functions for the structured, complete recording of the manufacturing process. For instance, by using the electronic recording mode during manufacturing, the processes can be transferred more easily from the development phase to commercial production. Track & Trace The Feature Package Track & Trace expands PAS-X with functions for serialization and aggregation in packaging processes. It integrates to the ERP level and to packaging equipment and line controllers on the production level, bridging Level 4 with Level 2. The goal is to help pharmaceutical companies meet the legal requirements for fighting product counterfeiting. 5

6 SUCCESS STORIES AstraZeneca, Sweden: Combined rollout of PAS-X and SAP at one of the largest tablet manufacturing plants Werum s PAS-X Manufacturing IT Business Platform provides SAP integration and harmonization of business processes on the shop floor AstraZeneca, the world s fifth-largest pharmaceutical manufacturer, simultaneously rolled out PAS-X, SAP and several other IT systems at its Swedish plant in Södertälje. With an annual output of over 10 billion tablets, the factory located south of Stockholm, is one of the largest tablet manufacturing plants in the world. AstraZeneca, Kontrast Foto In a first step Werum s PAS-X supports the manufacturing and packaging of blockbusters like Nexium and Symbicort with PAS-X Weighing & Dispensing for manufacturing and PAS-X Track & Trace for packaging. The PAS-X system replaces a legacy system and is being used throughout the shop floor on approximately 500 fixed and handheld terminals, and is fully integrated with SAP. With PAS-X, we now have a system that supports harmonization of business processes on the shop floor, said Thomas Hallgren, One of the world s largest tablet manufacturing plants relies on PAS-X. Business Relationship Manager, AstraZeneca. We get built-in business best practice and don t need to drive development to replace a bespoke set of systems. The current installation is our Manufacturing IT platform for future rollouts of MES functions like EBR and electronic logbooks. AstraZeneca selected Werum s PAS-X Manufacturing IT Business Platform as their standard MES product in view of its functional scope, its SAP integration capabilities and Werum s global support services. The AstraZeneca pharmaceutical group has already installed PAS-X in China, India and the USA. Werum s PAS-X becomes Novo Nordisk s central Manufacturing IT platform for different applications at various sites Go-Live of newest version of Novo Nordisk s MES Standard System at four Major Plants in Denmark, France and the U.S. / harmonization of production processes and transparency across sites The global healthcare company Novo Nordisk successfully rolled out the newest version of its MES Novo Nordisk Production of Novo Nordisk s insulin pens in Hillerød, Denmark. Standard System at production sites in Chartres (France), Hillerød and Kalundborg (Denmark) and in Clayton (North Carolina, USA). All four batch line plants run with the same consolidated MES Standard System using Werum s worldwide leading PAS-X Manufacturing IT Business Platform. With this new standard platform, Novo Nordisk harmonizes its production processes and achieves greater transparency across all sites. At the new plant in Kalundborg, Werum s PAS-X controls the filling of biopharmaceuticals. In Chartes, PAS-X supports the filling of insulin, whereas in Hillerød und Clayton it supports the packaging and assembly of insulin penfills. The coordinated PAS-X Go- Lives are part of Novo Nordisk s PAS-X Program, which started in This worldwide IT initiative is designed to shorten production lead times and reduce production costs. The program will also implement cross-plant standardization, improvements to production processes and optimized procedures for quality assurance. 6

7 PARTNERSHIPS A Milestone for Automated Pharmaceutical Production: Werum and Glatt develop first industry-specific Recipe Libraries for Granulation and Coating Werum and the Glatt Group, worldwide leading manufacturer of pharma equipment, present a new, jointly developed approach for setting up pharma production processes more easily. The construction kid for MBR creation is similar to Word or Excel templates, says Christian Wölbeling, Senior Director Marketing & Sales, Werum Software & Systems AG. Werum and Glatt customers do no Process Technologies Pharma, Glatt Group. Customers who purchase a machine from Glatt will also be provided with templates for granulation or coating. The new templates result from the long-term successful collaboration between Glatt and Werum and their broad experience in the field of pharma and biotech manufacturing. Werum and Glatt confirm their intensified collaboration. Werum s Manufacturing IT Business Platform PAS-X will include predefined recipe libraries for granulation and coating processes. The libraries are collections of industry-specific base elements enabling users to quickly build Master Batch Records (MBRs). The supplied MBR templates are tailored for the actually interfaced Glatt equipment and provide preconfigured standard processes as they generally occur in the manufacturing of pharmaceuticals. longer need to start from scratch when setting up production processes. From now on, customers can build their modeling on the base elements supplied by PAS-X. Another big advantage: The libraries are continuously updated. It is our goal to offer expandable standard solutions to our customers and thus make the automation of their production processes easier to handle, explains Thomas Hofmaier, Head of Business Unit Having implemented our integrated MES solution we have realized great benefit beyond our initial expectations. Since changing from paper to EBR we have seen a 50% reduction in scrap and 50% reduction in deviations. Through the fully interfaced solution and modeling guidelines implemented we can now predict the trend of deviations from our MES exceptions. Using the data within the system we will focus on implementing Review by Exception and Auto Release which will allow a significant reduction on Batch Record Review time. Barry Lawlor, Automation Technical Services Lead Janssen Pharmaceutical Companies of Johnson & Johnson 7

8 MANUFACTURING IT PAS-X Manufacturing IT Business Platform The smartest Distance between Development and Delivery In the field of manufacturing software, the trend is towards integrating different system components, such as MES, PD, IMP, Track & Trace, ELN and IPC, with the goal of creating great benefits. Against this background, Werum has developed PAS-X into a platform for Manufacturing IT a platform that covers all pharmaceutical process steps from Process Development to Commercial Production and Packaging. Focusing on the pharmaceuticals industry, PAS-X supports apart from the standard functions dedicated process types including fine chemicals, biopharmaceuticals, vaccines, solids and other manufacturing operations. PAS-X combines user-focused, role-based design with integrated industry best practices for a wide range of use cases. Paired with Werum s long-term expertise in the pharmaceutical industry, Werum, as your key implementation partner, will deliver the PAS-X product, support your validation, and provide installation support to assure a successful system launch. Scan me! Learn more about PAS-X at IMPRINT We use Werum s Manufacturing IT Business Platform PAS-X to develop and manufacture our internationally well-proven and innovative pharmaceuticals in novel drug delivery forms. PAS-X streamlines our production and packaging processes thus significantly reducing lead times and increasing efficiency. Dr. Jürgen Betzing Chief Operations Officer and Member of Group Management Acino Holding AG Publisher Werum Software & Systems AG Corporate Communications Wulf-Werum-Strasse Lueneburg Germany Tel.: +49 (0)4131 / Fax: +49 (0)4131 / info@werum.com 8