PAS-X Savvy Suite

Werum PAS-X Savvy, developed by Körber Pharma, is a collaborative data analysis platform designed for pharmaceutical and biotech companies seeking to accelerate product development, manufacturing, validation, and technology transfer. The solution enables organisations to manage, visualise, and analyse bioprocess data in real time across all phases of the product lifecycle, helping teams move from development to commercial production in an agile, secure, and robust manner.

By combining seamless data management, intuitive data visualisation, comprehensive data analysis, and automated reporting within a single platform, PAS-X Savvy unlocks the hidden potential of process data. The platform supports digital transformation by connecting information across all unit operations, enabling deeper process insights, identifying critical parameters, and ensuring consistent product quality.

Core Capabilities

• Data Management: Connect and contextualise large volumes of data from diverse sources and devices under high quality standards. Manage all available data across departmental boundaries, define personalised access rights, and work with time-series, sensor, quality, spectral, and image data within a single unified platform.
• Data Visualisation: Utilise an integrated, unique visualisation concept for an intuitive and clear representation of all bioprocess-relevant data. Maintain a holistic overview of processes, workflows, and projects, and generate meaningful plots within seconds.
• Data Analysis: Apply automated and integrated multivariate statistical analyses, adapt mechanistic models, or generate evaluations using artificial intelligence. The agile and flexible runtime environment supports all analyses through to reliable data interpretation.
• Automated Reporting: Automate repetitive reporting tasks using individually customisable templates for plots and reports. Export results directly to MS Word or MS PowerPoint, or prepare them for meetings and presentations via an interactive dashboard.

Process Models (PMs) — Integrated Process Modelling

• The Process Models application within PAS-X Savvy is an innovative feature enabling process engineers to assess the direct impact of every process input on the final drug substance.
• Users can identify which process parameters across all unit operations need to be optimised to improve active ingredient quality.
• Supports the definition of holistic control strategies and enables effective deviation management.
• Facilitates real-time batch release and specification-driven in-process control limits for Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs).

Key Benefits

• Create synergies: Connect expertise through systemic process analysis across teams, departments, and sites.
• Reduce costs: Accelerate time-to-market through robust and more efficient process development.
• Minimise risks: Deep insights into process workflows guarantee stable and consistent product quality.
• Saves time in managing data across multiple units, departments, and locations.
• Automates data analysis and reporting in both development and production environments.

Implementation Approach

1. Fit Phase (1 month): Assessment of the current data situation and design of a tailored target scenario for data management and analysis.
2. Build Phase (3 months): Construction and configuration of required interfaces to enable automated data import into PAS-X Savvy.
3. Go-Live Phase (1 month): System goes live with user training and minor optimisations provided by the Körber team.

Additional Services and Integrations

• CMC Consulting: Experienced CMC consultants support experiment planning, ICH-compliant control strategy setup, biosimilarity assessment, stability trending, and other statistical challenges during product launch.
• Complements other Körber software solutions including Werum PAS-X KPI for production line performance monitoring and Werum PAS-X Quality Reporting for automated quality report generation.
• A free one-month trial is available, with Körber's team providing support for optimal use of all platform features.
• Average successful implementation time is five months, with a structured and tailored implementation strategy to meet and exceed customer expectations.

PAS-X Savvy is suitable for pharmaceutical and biotech organisations at any stage of the product lifecycle, from early-stage development through to commercial manufacturing. The platform has been successfully deployed in collaboration with leading industry partners, including Boehringer Ingelheim Research Center Vienna, where it supported process characterisation studies and the establishment of scientifically sound control strategies.