PAS-X Biopharma Solution

The Körber PAS-X Biopharma Solution is a comprehensive manufacturing execution and data analytics platform designed specifically for the unique demands of biopharmaceutical and biotech production. More than 60 percent of the world's top 20 biotech manufacturers rely on PAS-X software to ensure flawless process execution, digital data management, and rapid batch review. Recognised as a Leader in the Gartner® Magic Quadrant™ for Manufacturing Execution Systems 2023, Körber's PAS-X is the trusted choice for biopharma organisations seeking to combine compliance, efficiency, and digital innovation.

Biotech manufacturing presents distinct challenges, including highly complex processes requiring strict real-time control, enormous volumes of data requiring analysis, continuous manufacturing demands, and the critical need to prevent the loss of extremely high-value batches. The PAS-X solution addresses all of these challenges through an integrated combination of software, content, and services tailored to biopharma workflows.

Key Challenges Addressed

• Complex biotech processes requiring stringent real-time control and monitoring
• Management and analysis of large volumes of process data
• Support for continuous manufacturing operations
• Prevention of costly batch losses through direct intervention capabilities

PAS-X MES – Manufacturing Execution System

• Enables 100 percent paperless, fully digitalised processes across batch execution, review, and documentation
• Ensures regulatory compliance throughout the entire biopharma production process
• Achieves a Right-First-Time rate of up to 98 percent
• Accelerates batch release significantly through Review by Exception functionality
• Supports upgrades without downtime, enabling uninterrupted continuous production
• Available as an on-premises solution, in the cloud, or as Software as a Service (SaaS)
• PAS-X MES as a Service reduces internal IT effort by up to 75 percent and lowers initial investment by 65 percent
• Offers pre-configured adapters and modern interfaces for seamless integration with existing automation environments, including fermenters, bioreactors, and analytical instruments
• Improves data provision for biosimilar development and regulatory submissions by storing and transferring data in a standardised, integrated format

PAS-X Savvy – Data Science Platform

• A cloud-based data science platform that combines biotech process knowledge with advanced data analytics techniques
• Collects, contextualises, visualises, analyses, and simulates biopharma process data in real time
• Reduces time-to-market by up to 50 percent
• Accelerates process development by 40 percent
• Reduces the number of experiments required by more than 50 percent, delivering significant cost savings
• Enables holistic control strategies, process optimisation, and reduction of failed batches
• Supports continuous process verification (CPV) during ongoing production through dedicated CPV functionality
• Seamlessly integrates with PAS-X MES data for end-to-end process intelligence
• Extracts and evaluates critical process parameters (CPPs) and critical quality attributes (CQAs) to meet biosimilar specifications

PAS-X Content Suite

• Included within PAS-X MES as a biotech-specific content layer
• Contains best-practice and biopharma-specific Master Batch Record (MBR) design elements
• Enables teams to accelerate the development of lean, high-quality MBRs

PAS-X Services

• PAS-X MBR Services allow biopharma manufacturers to outsource MBR design to Körber or receive expert consulting and health checks for existing MBRs
• PAS-X CMC Innovation Consulting supports the application of the right statistical tools for process development and validation, regulatory submissions, and product quality improvement
• Körber Academy provides training to improve employee skills and knowledge, available both online and on-site

Biosimilar and Personalised Biotech Production

• PAS-X solutions are optimised for biosimilar manufacturing, which requires extensive analysis and comparability studies to meet the same quality, safety, and efficacy standards as biologics
• PAS-X Savvy simplifies and accelerates data analysis by extracting and evaluating CPPs and CQAs relevant to biosimilar specifications
• Supports the development of complex models accounting for cell lines, production patterns, process parameters, and quality attributes
• Provides a systematic approach to ensuring analytical biosimilarity, maximising the chances of successful drug approval
• PAS-X MES delivers full traceability, compliance, and efficiency benefits in a paperless environment for biosimilar production

Key Business Benefits

• Reduced complexity through a single integrated solution with biopharma-specific functions and content
• Up to 98 percent Right-First-Time rate and accelerated time-to-market via Review by Exception
• Assured quality and compliance across the entire biopharma production lifecycle

PAS-X is available on-premises, in the cloud, or as a fully managed SaaS offering, providing flexible deployment options to suit different organisational needs. Körber actively collaborates with global biopharma forums, including ISPE (CoP Biotech), to develop technology roadmaps and share best practices, reinforcing its position as a thought leader and innovation driver in the biotech industry.