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With our Werum PAS-X MES - on premise or cloud-based - and our software solutions for analysis, track & trace, networked factories, and intelligent packaging, we are the world's leading supplier and partner to the pharmaceutical and biotech industries.

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As a technology leader we support you on the path towards Pharma 4.0 with innovative digital solutions along the pharmaceutical value chain. Together we optimize your OEE, create transparency and equip you for the future.

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We are specialists for complete handling systems for pharmaceutical and medical products. Our solutions are decisive in the field of contactless and safe transport of e.g. glass syringes.

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As the world's leading inspection expert, we develop solutions for the pharmaceutical and biotech industries. Our range of products extends from high-performance machines and semi-automatic machines to laboratory units and inspection applications for in-process control.

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Packaging materials

Packaging materials

As long-standing specialists, we develop packaging solutions for innovative and high-quality secondary pharmaceutical packaging made of cardboard. We offer you solutions for counterfeit protection, standard folding boxes and much more.

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We offer our customers a wide range of inspection solutions and quality controls at the highest level. Learn more about the right technology for your requirements.

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Packaging machines

Packaging machines

Our packaging machines ensure maximum flexibility and productivity for your packaging processes. Learn more about our modular, customer-specific packaging solutions.

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Packaging materials

Packaging materials

The demands on pharmaceutical packaging are high: it should be forgery-proof and childproof, but also compact and sustainable. Find out here how we make packaging future-proof.

Overview Packaging materials Services

About us

We at Körber in the Pharmaceuticals business area are the people to contact when it comes to pharmaceutical products. As a leading system provider, we advise our customers from the development and production to the inspection and packaging of their products.

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Werum PAS-X MES: The digital EBR for providers of cell therapy

Werum PAS-X MES enables you to digitally and automatically manage your entire production process, needle to needle, for cell and gene therapies. That way, your manufacturing operations are faster, more reliable and compliant.

As a manufacturer of cell therapies, you face extraordinary challenges due to the highly complex nature of the manufacturing processes of regenerative medicines including cell therapies, gene therapies and stem cell therapies. The manufacturing execution system Werum PAS-X MES enables you to digitally manage and control your production processes efficiently and flawlessly — from the time the personalized tailored medication is ordered, to its manufacture and the dispatch logistics, and finally, to its use and the subsequent examination and infusion of the drug to the patient.

At the same time, Werum PAS-X MES enables you to manage volumes of data when many patients are involved. You guarantee that the donated cells and the medication derived from them are uniquely assigned to patients during the entire process (chain of identity). This ensures that every patient receives his or her individually personalized medicine as quickly as possible. All events along the value chain are recorded during the entire process (chain of custody). Each and every member who is part of the process gets logged (chain of compliance).

Continuously optimizing production

Werum PAS-X MES automates your entire manufacturing process. You collect all of the data as it is generated and you receive the required information digitally in real time. This enables you to monitor and continuously optimize the entire production process. For example, electronic batch recording (EBR) creates standardized digital processes for equipment, warehouse and material management. Meanwhile, master batch records (MBR) enables you to quickly and easily create and manage master batch records to seamlessly navigate the process and deliver a right first time product. 

You reduce the time and effort needed for allocating, transporting and releasing batches, and also drastically reduce the risk of human error. In doing so, you also meet all of the strict compliance requirements for providers of cell therapies. Moreover, your projects always stay within the planned budget and timeframe. And after a therapy has made its mark in clinical trials, you can easily scale it up for commercialization while having all data at your fingertips.

lWith Werum PAS-X MES, Walvax has been able to gain advantages in terms of compliance, process standardization and acceleration of batch release.r

Huang Zhen, President Walvax Biotechnology Co., Ltd. Yuxi

Leading US and Chinese manufacturers use Werum PAS-X MES

Körber is the market leader in digital manufacturing solutions for the cell and gene industry and has been an active part of the cell and gene manufacturing industry with its manufacturing IT solution Werum PAS-X MES since the first FDA approval of a therapy took place in 2017. Today, for example, leading cell therapy manufacturer Takeda uses Werum PAS-X MES for data and tech transfer at its manufacturing site in Cambridge/Massachusetts/USA. And China’s leading vaccine manufacturer, Walvax Biotechnology, has implemented Werum PAS-X MES in its Yuxi plant as a major part of its digital factory.

lWith the help of Werum PAS-X MES we have been able to establish a paperless factory from scratch. The digital operations ensure seamless data and technology transfer between our cell therapy sites when scaling-up from clinical trial to commercial manufacturing.r

Viraj Tyagi, Head of Technical Alliances & Digital, Takeda Cell Therapies

Körber is a member of the Alliance for Regenerative Medicine (ARM), the leading international advocacy organization committed to realizing the promise of regenerative medicines and advanced therapies. By working with ARM, Körber is dedicated to supporting regenerative medicine and continuously innovate its digital solutions for the cell & gene therapy industry.

Alliance for Regenerative Medicine (ARM)

Körber has also joined the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), a community of biopharma manufacturers who are striving to do groundbreaking research in the field of big data, cell & gene and others to develop manufacturing capabilities in the USA. With its memberships Körber seeks to strengthen networks and to achieve closer cooperation in leading biopharmaceutical production innovations.

National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)

lWe are proud to be part of the ARM, the International Society for Cell and Gene (ISCT), the NIIMBL and others who allow us to continue our mission to save patients’ lives and solve the most challenging problems in the biomanufacturing space such as big data and cell & gene therapy.r

Dr. Judith Koliwer, Lead Consultant Software, Körber Business Area Pharma

Your benefits

A platform of solutions from a single source

Werum PAS-X MES provides you with a comprehensive platform of solutions from a single source — including specific functions and content for cell culture production

Thoroughly configurable and scalable

Continuous process optimization by means of automation as well as functions such as electronic batch recording and master batch recording

Analyze massive data volumes of patients and cells

Electronic availability of patient data in real time — for the amount of data generated by large numbers of patients and starting material cells

Whitepaper: Why cell & gene CMOs must embrace digitization

Learn how Electronic Batch Recording (EBR) enables the identification of the material at any point in time, thus facilitating ATMP compliance.

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Brochure: Cell & gene therapy

Learn more about speeding up cell & gene therapy for patients with Werum PAS-X MES.

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Whitepaper: Cell & Gene

The white paper addresses specific production issues in the context of "Cell & Gene" therapy. It explains how these challenges can be solved with the help of a Manufacturing Execution System (MES).

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Whitepaper: Digitization of supply chain

This white paper discusses the unique biopharmaceutical supply chain challenges of cell & gene therapy logistics and recommends forward-thinking solutions to address them.

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Werum PAS-X MES Suite

The market-leading Werum PAS-X MES suite controls, monitors, and documents your processes digitally in real time across the entire production cycle.

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Werum PAS-X MBR Design & Execution

Werum PAS-X Master Batch Records simplifies the production process for these highly complex manufacturing work instructions, while Werum PAS-X Electronic Batch Recording ensures reliable execution and documentation.

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Any questions?

Get in contact with us. We are happy to advise you about our solutions and services.

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