The road to commercial manufacturing for Cell & Gene therapies

Werum’s PAS-X MES targets the key challenges for cell therapy manufacturers, managing complex processes and controlling the chain of identity.

Imagine you are an up and coming cell therapy company. You have gone through the exploration phase, and are in the process of finalizing a breakthrough treatment.

When scaling-up to commercial manufacturing, electronic systems are emerging as the only option for managing complex processes and controlling the chain of identity.

Werum’s PAS-X MES is ideally suited to target the key challenges for cell therapy manufacturers through its capabilities to automate calculations and workflows.


Among our references are many of the largest and most demanding pharmaceutical manufacturers worldwide who deployed PAS-X in very large installations on a global scale as their standard manufacturing execution system and therefore cooperate with several companies.

PAS-X Material Flow & Inventory secures in-plant material flow throughout the pharmaceutical manufacturing process. It contains sub functions for manual and automatic transport control as well as in-plant administration of shop floor storage areas.

The precise weighing and dispensing of input materials based on recipe specifications is the core of any pharmaceutical manufacturing process. Accurate data collection within this first processing step is fundamental to batch tracking and documentation. In a reliable and "easy-to-operate" way, PAS-X Weighing & Dispensing guides the user through the weighing process and provides the necessary support for compliance with safety regulations and recipes. It supports manual as well as automated weighing and dispensing operations. Many Werum customers start their electronic manufacturing projects with the WD function and scale up later according to their needs. This function is also available as an entry-level solution.

PAS-X Finite Scheduling – now powered by sedApta’s Factory Scheduler, whose standard functions are seamlessly integrated into PAS-X MES – is covering the production planning process. The function enables the detailed scheduling of your production processes and resources with finite capacity, the optimization of production sequences as well as the management of materials and multi-scenario analyses. Benefit from a higher quality of scheduling results with real-time feedback, less implementation effort thanks to a pre-tested, out-of-the-box interface, joint master data management and high visibility across multi-tier networks to reduce inventory.

Our Plug & Produce solution allows a fast and easy integration of machines and automation systems into a pharmaceutical production environment – a prerequisite for the implementation of many Industrie 4.0 solutions.

PAS-X is the market-leading MES (manufacturing execution system) for the pharma and biotech industries. It is run by more than 50 percent of the world’s top 30 pharmaceutical and biotech companies and in more than 1000 installations around the globe.

PAS-X Manufacturing Intelligence helps you to enhance the shop floor performance within your manufacturing processes. For instance, our PAS-X KPI Solution supports operators and supervisors on the shop floor as well as production site managers to constantly monitor operational performance data from the shop floor. The live monitoring of the production and packaging lines allows optimizing processes or equipment very quickly, thus boosting your operational performance. PAS-X KPI is also available as a lean standalone software solution for fast and easy implementation.

PAS-X Process Quality Control captures events and deviations enabling companies to drastically reduce batch review and release time and to implement Review by Exception. It ensures a continuous monitoring of the production quality. In order to achieve the highest possible quality and to take preventative and flexible measures, PAS-X Process Quality Control supports process-analytical on-line, in-line, and at-line quality controls. The function supports the implementations of Process Analytical Technology (PAT) and state-of-the-art Quality by Design (QbD) concepts.

PAS-X Warehouse Management supports production-related warehouse logistics. The system components can be configured as required, and form the basis for implementing warehouse management systems, control systems and picking systems.

PAS-X Equipment Management administers and monitors cleaning procedures and statuses for all types of production-related objects. This includes MBRs and particular rules for cleaning scales, work rooms, containers, production equipment, setup parts and toolkits. Electronic paperless equipment logbooks keep status lists, cleaning rules and histories for individual container types.

Efficient electronic batch documentation is one of the most important objectives in introducing an MES to pharmaceutical production. With PAS-X Electronic Batch Recording all MBRs are electronically executed and the processes and results are documented in compliance with the applicable statutory provisions. PAS-X EBR ensures an error-free and guided execution of the entire production process and right-first-time manufacturing.

PAS-X Master Batch Records allows the customer to easily set up and maintain libraries with standardized, reusable building blocks which can then be used to create an MBR.


Körber Pharma Software

8000 Regency Pkwy #403

Cary, NC 27518


Phone: 973-646-3408

Contact: Shawn Opatka


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