Specialty Biopharmaceutical Company

This international biopharmaceutical company provides treatments in neuroscience, rare diseases, gastrointestinal, and internal medicine.

Specialty Biopharmaceutical Company

This international biopharmaceutical company provides treatments in neuroscience, rare diseases, gastrointestinal, and internal medicine.

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The Statistica validated data system represents a significant step toward better understanding of our process technology and higher business efficiency.

Director of Manufacturing Systems

Specialty Biopharmaceutical Company Discovers Data Analysis and Process Efficiencies

Better visibility, easier compliance, less risk and cost, higher quality

Challenge

This company's US operations of its Rare Diseases Business Unit relied on a mix of in-house scripts and tools to manually aggregate critical production process data, which was cumbersome and tedious.

Solution

To support FDA regulated manufacturing operations, the division decided to move to a single solution that would provide controlled access to validated process data and validated analytic workflows. The key requirement was that the solution be an off-the-shelf application with validated output and demonstrated use in the biopharma industry.

After careful evaluation, the organization selected the TIBCO Statistica™ advanced analytics platform and implemented the solution in development, validation, and production environments across multiple manufacturing sites.

Benefits

Empowered Employees

With simple tools and data-entry capabilities, users access the single Statistica™ system to aggregate data from multiple sources, create models, and produce reports and statistical analyses. Change management has been improved and streamlined as teams and individuals are empowered to apply statistical principles and perform ad hoc analysis for more granular segmentation or personalization. The system publishes reports automatically, freeing up staff time and providing immediate and broader access and transparency.

Without Statistica, the company would have been forced to spend hundreds of thousands of dollars and deploy a dedicated staff to develop code and maintain the system. Instead, regular users have sophisticated functionality in a simple, intuitive analytical tool. Data consumers can aggregate data in the ways they want to see and analyze it, and create tables and analyses as needed. Using Statistica Enterprise Workspace, the company easily combines data originating from multiple sources to perform ad hoc and predefined analyses that don't require custom coding.

"The Statistica validated analytics system represents a significant step toward better understanding of our process technology and higher business efficiency," says the director of manufacturing systems.

Easier Compliance, Better Visibility, Less Risk

A secure and validated analytics environment with auditable workflows and reports to support end-to-end manufacturing processes, the Statistica system fulfills all of the division's compliance requirements as dictated by the FDA and other international agencies.

By aggregating data from multiple sources and using Statistica to build very complex and comprehensive models, users gained unprecedented visibility into manufacturing processes. These capabilities have helped the company minimize risk by making it simple to rapidly detect emerging issues and take corrective action.

Fast Deployments to Support Six Product Lines

All this capability inside one analytics environment enabled deploying Statistica in record time to support six commercial product lines. Following the first implementation, each subsequent deployment was significantly streamlined. The team simply adheres to proven installation and compliance practices to ensure fast and trouble free deployment in eight weeks, extremely efficient for a biologics manufacturing plant.

Increased Efficiency, Reduced Costs, Higher Quality

Users benefit from applying real-time insights across the entire production process. Verified data and reports are visible across sites, which increases efficiency, reduces cost, and improves communication. For example, the division achieved a new understanding of raw material usage. It can now readily identify the most critical factors that influence product quality and process performance. The Statistica system is being used to better understand how raw materials behave during certain steps in the production process. Historical trends, comparisons of protein production in the bioreactor, and yield profiles during purification have produced valuable insights that enabled adjustments for a resulting increase in productivity and efficiency.

Most importantly, continuous process monitoring is supporting proactive interventions to stop negative trends, boosting product quality. Increased predictability of production performance has helped reduce process variability and the risk of lost batches.

35-75%

Cost reduction
Case Study