PAS-X for Cell and Gene Therapy

Werum PAS-X MES is a Manufacturing Execution System (MES) purpose-built to support the highly complex and manual-intensive production processes involved in cell and gene therapy (CGT) and tissue engineering. Developed by Körber Pharma, it is designed for emerging biotech companies, contract development and manufacturing organisations (CDMOs), and established CGT manufacturers seeking to digitise their operations, ensure regulatory compliance, and accelerate time to market. PAS-X MES is available for deployment on-premises, in the cloud, or as a fully managed Software as a Service (SaaS) offering.

Cell and gene therapy manufacturing presents unique challenges, including high process complexity, a large number of manual steps, difficulty in finding and retaining qualified personnel, and evolving regulatory requirements. PAS-X MES addresses these challenges through digital process documentation, guided operator workflows, and real-time review capabilities, making manufacturing faster, more reliable, and compliant throughout the entire product lifecycle — from clinical trials through to commercial production.

Core Capabilities for Cell and Gene Therapy Manufacturing

• Electronic Batch Recording (EBR): Enables fully paperless documentation of manufacturing processes, supporting operators and laboratory personnel through barcode scanning, automatic user tracking, Chain of Identity, and Chain of Custody management.
• Operator Guidance: Provides step-by-step operator guidance, automatic calculations and decision support, mix-up prevention, equipment checks, and material usability verification to reduce errors in complex manual processes.
• Review by Exception: Streamlines the review process for supervisors and quality departments by providing a clear process overview, reducing documentation issues, and enabling real-time Review by Exception.
• Master Batch Records (MBR): Simplifies highly complex manufacturing instructions through Werum PAS-X MBR Design and Execution, ensuring safe and consistent process execution and documentation.
• Real-Time Patient and Cell Data Analysis: Enables electronic availability of patient data in real time, supporting the processing of large data volumes at high patient numbers and with large quantities of source cell material.

Complete Product Lifecycle Coverage

• PAS-X MES supports Electronic Batch Recording across the entire product lifecycle, beginning with clinical trials where processes are subject to frequent changes.
• Körber has developed a best-practice approach to ensure EBR remains efficient and practical at every phase of the product lifecycle.
• An iterative approach combining process digitalisation, data analysis, process optimisation, and validation enables CGT manufacturers to significantly reduce time to market.
• Integration with Werum PAS-X Savvy enables automated data analysis, allowing manufacturers to continuously improve and validate their processes.

Digital Data Management and Regulatory Compliance

• Addresses the specific data management challenges of CGT processes, including large volumes of data generated during complex procedures and high process variability due to diverse input materials.
• Provides data in digital form from an early stage, enabling manufacturers to keep pace with evolving regulatory guidelines and new approvals.
• Digital data can be directly processed with PAS-X Savvy or other data analytics tools, supporting continuous process improvement and compliance.
• Supports ATMP compliance by enabling material identification at every point in the process through EBR.

Key Benefits

• A single, comprehensive platform for manufacturing IT solutions, including specific functions and content for cell culture production.
• Continuous process optimisation through automation, Electronic Batch Recording, and Master Batch Records.
• Scalable from clinical-stage operations to full commercial manufacturing, supporting seamless data and technology transfer across production sites.
• Enables the construction of fully paperless manufacturing facilities from the ground up.

Ecosystem Partnerships and Integrations

• Körber collaborates with specialist solution providers to enable best-practice integration of PAS-X MES into a complete digital ecosystem for cell and gene therapy.
• Partners include TrakCel and HyperTrust, which provide tailored traceability solutions for personalised medicine, and sedApta, which offers finite scheduling capabilities suited to the complexity and process flexibility of CGT manufacturing.
• Integration with OCELLOS supports system-level process tracking for cell and gene therapies.
• Körber is an active member of industry bodies including ARM, NIIMBL, ISPE, ISCT, and BioPhorum, enabling collaboration across the CGT ecosystem.

PAS-X MES has been adopted by leading manufacturers globally, including Takeda, which uses the system for data and technology transfer at its cell therapy production site in Cambridge, Massachusetts, and Walvax Biotechnology in China, which implemented PAS-X as a core component of its digital factory. Körber has been an active participant in the CGT industry since the first FDA approval of a cell therapy in 2017, and continues to support manufacturers in scaling from clinical trials to commercial production with flexible deployment options and a proven best-practice implementation methodology.