Software for the pharmaceutical and biotech industries — your path to digital production

Software for the pharmaceutical and biotech industries — your path to digital production

Do you want efficient, safe, and flawless production processes? If so, you should control and monitor your production digitally with the help of the worldwide market-leading systems Werum PAS-X MES Suite and Werum PAS-X Intelligence Suite along with other Körber software solutions for pharmaceutical and biotech companies. This is how you exploit the whole potential of your value chains.

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Werum PAS-X MES Suite

Werum PAS-X MES Suite: Producing drugs safely and efficiently

For your efficient and error-proof production: Our world-leading Manufacturing Execution System (MES) Suite Werum PAS-X controls, monitors, and documents your processes digitally and in real time throughout the entire manufacturing cycle.

Körber’s PAS-X MES Suite enables you to reduce the error rate and the manufacturing costs. In addition, you can shorten time-to-market and increase efficiency for your company.

Werum PAS-X MES covers the entire production cycle of the pharmaceutical, biotech, and cell & gene therapy industries — from process development and commercial production to packaging. The production management system includes all important functions for manufacturing in a modular way. PAS-X can be implemented out of the box and smoothly integrates all surrounding IT systems via standard interfaces.

Werum PAS-X MES from Körber has established itself as the leading MES for the pharmaceutical, biotech and cell and gene therapy industries. It is used by more than 50 percent of the top 30 companies in the industry worldwide, as well as by many medium-sized manufacturers.

PAS-X users constitute the world’s largest MES community in the pharmaceutical and biotech industries. Via our PAS-X user forum “PAS-X For Us” (PFU) many of our customers actively participate in the further development of the software - thus ensuring that our product always bundles the most successful methods from the pharmaceutical and biotech industry.
 

White Paper: 5 benefits of using an MES for pharma and biotech

How to save time and effort and avoid risk in your pharma or biotech production.

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PAS-X covers the entire manufacturing cycle

Selected functions of Werum PAS-X MES Suite

Werum PAS-X Weighing & Dispensing

Weigh and dispense input material digitally and exactly in accordance with the recipes, thanks to Werum PAS-X Weighing & Dispensing. This makes your weighing and dispensing processes more precise, more efficient, and more fail-safe. 

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Werum PAS-X MBR Design & Execution

Does your production process follow highly complex master batch records? If so, PAS-X Master Batch Records simplifies your processes by means of digital documents, while PAS-X Electronic Batch Recording ensures reliable execution.

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Werum PAS-X Track & Trace

Effectively combat counterfeit drugs. The serialization solution Werum PAS-X Track & Trace enables regulatory authorities and customers to seamlessly track the path and identity of your medical products at any time.

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Werum PAS-X Business Functions

Werum PAS-X MES is a modular system that you put together in accordance with your needs. In doing so, you can employ all functions as separate solutions or combine them with one another.

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Werum PAS-X Add-ons

Werum PAS-X Add-ons: Expand your range of uses

The Werum PAS-X Add-ons allow you to expand the range of applications for your Werum PAS-X MES Suites.

Does your production process pose special challenges? Would you like to exploit the full potential of your Werum PAS-X Suites MES even more effectively and take advantage of new areas of application? The Werum PAS-X Add-ons allow you to enhance the capabilities of your existing suites and solutions through new features, enabling intuitive user experience.

Every Werum PAS-X Add-on connects seamlessly to your Werum PAS-X MES Suites and solutions. Thus, you directly benefit from a whole range of new functions — from biometric user authentication via automated collection and processing of production data through to fast integration of new equipment. You will exploit the full potential of your Werum PAS-X MES Suite and solutions more efficiently than before.
 

Selected Werum PAS-X Add-ons

Werum PAS-X K.ME-IN: Fast and secure biometric authentication

The biometric solution Werum PAS-X K.ME-IN enables quick, convenient and secure authentication of authorized users of your Manufacturing Execution System.

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Werum PAS-X Plug & Produce: Quick and easy integration of new equipment

The Werum PAS-X Plug & Produce solution allows you to connect your MES with your machines to form intelligent digital networks.

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Werum PAS-X Content Suite

Werum PAS-X Content Suite: Content for the fast deployment of your Werum PAS-X MES

With Werum PAS-X Content Suite you can quickly set up PAS-X systems for different industries such as pharma, biotech, and cell & gene therapy. For this purpose, our Content Suite provides you with pre-parameterized content supporting you whilst you configure your specific Werum PAS-X MES system. You can rapidly implement your own business processes with the help of our consultants and best-practice content for a wide range of applications. This saves you time and reduces risks.

The Werum PAS-X Content Suite provides you with a total of 14 content packages for three application areas:

  • Administration
  • Process Libraries 
  • Equipment Libraries

Content packages for three application areas

Administration

  • Equipment — for the design and documentation of equipment status diagrams. The package also includes ready-to-use best practice status diagrams for e.g. cleaning, assembly, sterilization, operating resources
  • Master Data — describes in detail the master data required for using the PAS-X system. It explains specifics regarding the master data and considers the sequence for creating master data
  • Reports & Labels — contains GMP-compliant templates for reports and labels as well as pre-configured reports, such as MBR reports and batch reports
  • Rights & Roles — supports the configuration of the PAS-X user rights based on global, GMP-compliant profiles and specific roles such as operator, supervisor, and QA/QM personnel
  • Workflows — delivers preconfigured workflows for reviewing and approving MBRs and EBRs including the evaluation of deviations

Process Libraries

Process Libraries support the standardization of manufacturing processes, the harmonization of processes at different sites and the development of lean MBRs.

Content packages are available to manage all steps for efficient and fast production. The following pharmaceutical production processes are available:

  • Cell & gene
  • Biopharmaceuticals
  • Pharmaceutical fine chemicals 
  • Solids 
  • Fill & finish for sterile production
  • Packaging

Equipment Libraries

  • Equipment Integration — includes best practice guidelines for equipment integration into PAS-X, as well as ready-to-use best practice state machines and MBR design elements
  • Equipment Supplier Specific — contains MBR design elements to create MBRs for the integration of specific pharma and biotech equipment such as granulators, tablet presses or packaging lines
  • LIMS Integration — provides several best practice MBR workflows for the integration of data exchanged between LIMS or similar systems and Werum PAS-X EBR

Werum PAS-X Intelligence Suite

Werum PAS-X Intelligence Suite: smooth production thanks to smart data analyses

Make data-based decisions to optimize your production process. With Werum PAS-X Intelligence Suite, you can collect, manage, analyze, and visualize production data in a quick and easy manner.

Do you want your production to run smoothly and manufacturing problems to be quickly and accurately resolved to get the most out of your production process? To achieve this goal, you need a comprehensive overview of your production data. With Körber’s Werum PAS-X Intelligence Suite, you can keep track of the processes in your factory at all times, identify contexts and recognize errors in the production process – allowing you to take corrective actions promptly if necessary.

Werum PAS-X Intelligence Suite enables collection and contextualization of relevant production data from a variety of sources to make it accessible for easy and quick use. You can apply a number of tools to process and analyze this data for a clear visualization of the results. If any problems or delays occur, our products’ smart algorithms will warn you in due time, allowing you to initiate appropriate countermeasures. This way, you can boost your yield, reduce production costs, and make more efficient use of active ingredients.
 

lWe offer out-of-the-box solutions that can benefit the users’ business right after being put into operation. Our goal is the quick and easy optimization of factory value chains. r

Albert Landman, Head of EMI Product Management Software, Körber Business Area Pharma

Whitepaper: AI for the pharmaceutical and biotech industries

How can Artificial Intelligence be used in the pharmaceutical and biotech industries in order to exploit optimization opportunities?

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Selected Werum PAS-X Intelligence products

Werum PAS-X Savvy: Data management and data analysis

Werum PAS-X Savvy from Körber combines the management, visualization, and analysis of data from a variety of sources using automated reports of the findings in an intuitive software environment. This way, you can accelerate pharmaceutical and biopharmaceutical product development, ensure product commercialization, and optimize productivity.

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Werum PAS-X KPI: Key Performance Indicators at a glance

Werum PAS-X KPI provides Key Performance Indicators (KPIs) in real time. This allows you to identify weak points at a glance and improve the efficiency of production and packaging lines. Via one single user interface, you can compare operational data of equipment from different plants or retrieve the data history of individual machines. 

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Werum PAS-X Quality Reporting: Faster reporting at a higher level of quality

With Werum PAS-X Quality Reporting, you can create quality reports automatically, including all relevant statistics – even across various locations. This standardized and automated process saves you time and effort, while also minimizing risks to data integrity.

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Werum PAS-X Data Access: Meaningful processing of MES data

Werum PAS-X Data Access automatically collects production data from your Werum PAS-X MES and processes it for various evaluations.

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Werum PAS-X Cell & Gene Solution

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.

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

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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PAS-X For Us

PAS-X For Us: How to enhance Werum PAS-X MES with us

The slogan of PAS-X For Us (PFU) could be: “Learning from our customers.” After all, who knows better how to optimize Werum PAS-X MES than the people who use it on a daily basis.

Companies that employ Werum PAS-X MES have joined us in the PAS-X User Forum in order to assist the development of first-rate MES technology and the associated services. For us at Körber, the PFU is seen as a competent business partner that supplies practical suggestions for the further development of Werum PAS-X MES.

How the PFU works

The PAS-X User Forum aims to improve the software functions and processes. To this end, the members formulate and prioritize new requirements and suggestions — both to enhance Werum PAS-X MES functions and to strengthen our services and work processes at Körber. The PFU focuses especially on close cooperation between the various Werum PAS-X MES users and Körber and on sharing experiences and best practice examples.

Become a PFU member!

We invite all active Werum PAS-X MES customers to join the PAS-X User Forum.
Companies that actively take part in the PFU as members can gain a competitive edge through the exchange of specialist know-how. 

Get in touch with us at: pfu-support.ph.software@koerber.com
 

Brochure: PAS-X For Us (PFU)

Partnership for building first-rate MES solutions

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Your benefits

Faster product launch

Right First Time

Full compliance

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Here you can find more background information about our solutions and services in our brochures, flyers, white papers and case studies.

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Werum PAS-X Services Suite

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