Solutions

We have a solution for everything – and the corresponding experience. In our current seven areas of expertise, we are at your disposal with our comprehensive know-how.

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24/7 available for you: In our virtual showroom, we present our extensive portfolio and latest innovations. 

Software solutions

Software solutions

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.

Overview Software solutions

Handling systems

Handling systems

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.

Overview Handling systems

Inspection machines

Inspection

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.

Overview Inspection

Machine finder

Packaging machines

Packaging machines

We are a leading supplier of packaging machines for liquid and solid pharmaceutical and medical products. With our blister, sachet and stick packaging machines we offer solutions for primary packaging. Our side and topload cartoners set standards worldwide for secondary packaging.

Overview Packaging machines

K.Pak Topload Case Packer

Introducing our latest solution from Körber; the K.Pak Topload Case Packer! Created specifically for the pharmaceutical industry, the K.Pak solution provides operator-friendly machines to complete any production line. Our solution focuses on innovative technology, high-quality design and expert handling and packaging of your product. It’s time to start connecting the dots with Körber!

Packaging solutions

Packaging solutions

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.

Overview Packaging solutions

Consulting

Consulting

Our experts will advise you during the analysis of your requirements, show you optimisation potential and support you during the implementation of projects in all areas of the pharmaceutical, biotech and medical device industry.

Overview Consulting

Software

Werum PAS-X MES: electronic batch recording (EBR) for cell & gene therapy

Werum PAS-X MES facilitates cell & gene therapy manufacturing by digital process documentation, operator guidance and review by exception. That way, your manufacturing operations are faster, more reliable and compliant.

Cell & gene therapy as well as tissue engineering processes are usually highly complex and contain many manual steps. Moreover, skilled personnel for execution and review is hard to find, which can limit the scale up of production. To address these challenges, cell & gene companies rely on PAS-X MES, which facilitates

  • the documentation of the process for the operators or lab personnel by barcode scanning, automatic tracking of users, chain of identity and chain of custody
  • the execution by operator guidance, automatic calculations and decisions, prevention of mix-ups, equipment checks and material usability
  • the review process for supervisors and quality departments by providing a process overview, reduced probability for documentation issues and real time review by exception 

Factsheet: Faster time to market through digitization of the complete product lifecycle

Werum PAS-X MES and Werum PAS-X Savvy enable automated data analysis in cell & gene therapy manufacturing. By leveraging an iterative approach of process digitalization, data analysis, process optimization and validation, CGT companies can drastically reduce time to market.

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Covering the complete product lifecycle

Most cell & gene therapy manufacturers who have implemented Werum PAS-X MES are using electronic batch recording (EBR) over the complete product lifecycle, beginning with clinical trials. During this phase, most manufacturers face constant changes to the process, which provides specific challenges for the implementation of a digital manufacturing system. 

Körber has developed a best practice approach to ensure that EBR is used efficiently and feasibly in all stages of the product lifecycle. By leveraging an iterative approach of process digitization, data analysis, process optimization and validation, our customers are able to drastically reduce time to market.

lTogether with Körber, we are achieving our ambitious GMP technology roadmap that enables our teams to focus on the core business – the production of therapies for people with cancer.r

Kawa Chiu Vice President of CMC, Supply Chain and GMP Systems, Lyell

Digital data management to keep up with legal requirements

Data management is particularly challenging for cell & gene therapy processes. Many new regulatory guidelines are frequently developed to stay abreast with new approvals. Furthermore, with the complex procedures, substantial amounts of data are generated and the different input material of many therapies leads to high process variability. By providing the data in a digital form early in the product lifecycle, PAS-X MES enables cell & gene therapy manufacturers to improve their data management. The digital data can be used directly with PAS-X Savvy or other data analysis tools.

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 & gene industry. It has been an active part of the industry with its Werum PAS-X MES since the first FDA approval of a therapy took place in 2017. PAS-X MES can be deployed in your data center, in the cloud or fully managed as Software as a Service

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

Partnering to ensure a digital cell & gene ecosystem

Cell & gene therapy processes require a digital ecosystem that reflects the specific needs of this industry segment. Companies like TrakCel and HyperTrust have developed tailored solutions for the traceability requirements in personalized medicine. Finite scheduling solutions like sedApta provide planning capabilities that take the huge complexity and process-derived flexibility into account.

Körber has partnered with these, and other world class solution providers, for many years to provide easy and best practice integration of PAS-X MES into a perfect cell & gene therapy digital ecosystem.

To learn more about evolving cell & gene therapy with MES and cell orchestration, please read our interview with Dr. Matthew Lakelin (TrakCel) and Dr. Judith Koliwer (Körber).  

To the interview

lCell & gene therapies are an emerging approach for the treatment of cancer, rare diseases and many more. As members of societies like ARM, NIIMBL, ISPE, ISCT and BioPhorum, we are able to collaborate with all players and learn from each other to ensure the best solution for our customers, the industry and most of all: the patient.r

Dr. Judith Koliwer, Principal 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 C(D)MOs benefit from 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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Whitepaper: Addressing Cell and Gene Therapy Manufacturing Challenges with Digital Solutions

The increasing demand for CGT requires scaling of production pipelines. Digital solutions are needed to support commercial production. In our whitepaper, we analyze the impact of Pharma 4.0 on CGT manufacturing and look at different options such as cloud-based and software-as-a-service offerings.

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Factsheet: Faster time to market through digitization of the complete product lifecycle

Werum PAS-X MES and Werum PAS-X Savvy enable automated data analysis in cell & gene therapy manufacturing. By leveraging an iterative approach of process digitalization, data analysis, process optimization and validation, CGT companies can drastically reduce time to market.

Download

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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