Smart IT Platform for Bioprocessing Control, Visualization, and Analytics

Challenge

QUBICON needed a digital platform that would modernize and streamline the way bioprocesses are monitored and analyzed. The goal was to develop a scalable software product that would enable pharmaceutical manufacturing teams and R&D laboratories to visualize bioreactor performance in real time and support efficient decision making.

In addition to data visualization and control, the solution had to offer predictive analytics, support regulatory compliance, and allow for flexible licensing management in multi-tenant environments.

Solution

In tight collaboration with QUBICON’s experts, SaM Solutions’ team developed an all-in-one software platform built on a central data architecture. Here are the core features that were implemented.

• Centralization: The solution collects and integrates data from online, at-line, and offline equipment into a unified system, forming a single source of truth for bioprocess monitoring and control.
• Visualization: The platform offers a highly visual environment for data interpretation. With real-time graphs, project-specific views, and the ability to display up to five y-axes in a single chart, users gain full transparency and insight into every critical process variable.
• Real-time monitoring: Data from process units and external analyzers is visualized immediately through a dynamic and customizable dashboard. Equipment is connected via OPC UA or PAT-Box, allowing for seamless in-process quality control and early detection of deviations that could lead to batch rejection.
• Intelligent data comparison: The application continuously compares live bioprocess parameters with reference runs. It calculates key performance indicators and soft sensors on the fly, highlights deviations, triggers alerts when thresholds are breached.
• Predictive analytics: The integration of predictive analytics functions based on modern mathematical models that simulate reactor performance under various scenarios. These features allow bioprocess engineers to optimize production strategies before they’re implemented on the shop floor.
• Client-server architecture: The platform’s client-server architecture supports unlimited access points, enabling teams to manage and process complete datasets, sampling values, and single measurements with ease.
• Flexible control: The support for various communication interfaces and data protocols ensures flexible integration with various devices, guaranteeing full compatibility with lab and production environments.
• Standard compliance: The software is designed to comply with industry standards, including Good Manufacturing Practice (GMP) and FDA 21 CFR Part 11, and features a flexible licensing system tailored for SaaS-based distribution.

Additionally, the UI/UX was completely reimagined to provide a clean, intuitive user interface that facilitates onboarding and minimizes the learning curve.

Success

With SaM Solutions’ support, QUBICON now helps its clients transition from manual, spreadsheet-based workflows to fully digital operations that adhere to Good Manufacturing Practice (GMP).

QUBICON’s offering transformed into a scalable SaaS product used by companies from the life science industry to improve process transparency, reduce risk, and increase operational efficiency. With predictive modeling and an intuitive interface, users can now simulate and adjust bioprocesses before implementation, avoiding costly errors and ensuring consistent product quality.

The flexibility of the developed platform allows for seamless integration of various devices, while its scalable architecture supports continuous growth. As a result, QUBICON is now better positioned to adapt to various business models and serve global manufacturers.

The partnership between QUBICON and SaM Solutions continues to evolve.