Problem

Astellas needed a single digital backbone to support fast-moving gene therapy production, one capable of ensuring consistency, compliance, and scalability. The facility operated multiple large-scale bioreactors used for producing viral vectors for gene therapy manufacturing. Delivered as independent OEM skids, the existing reactor systems had proprietary control interfaces, limiting visibility across the manufacturing process.

Additionally, the existing environment lacked centralized electronic batch record capabilities, automated reporting, and integrated alarm monitoring. As the facility expanded operations, these limitations created challenges for scaling production and maintaining consistent operational workflows.

Astellas needed a unified supervisory platform capable of integrating multiple OEM reactor systems, enabling centralized batch management, improving operational visibility, and supporting regulatory compliance under 21 CFR Part 11.

This project presented several technical and operational challenges.

OEM System Integration

The bioreactor control environment operates as a closed OEM platform built on Siemens control logic. To integrate this system, E Tech needed to perform detailed analysis of the proprietary control structures to expose appropriate process data points through OPC UA without compromising reactor operation.

Mapping ISA-88 Batch Structures

E Tech had to map control modules, equipment modules, and phases from the OEM environment into Ignition in a way that preserved batch logic while enabling centralized orchestration.

Life Sciences Compliance Requirements

The system had to support strict regulatory standards including:

• 21 CFR Part 11 electronic signatures
• Secure authentication and role-based access
• Fully compliant audit trails
• Validated batch reports

Extending Sepasoft Functionality

E Tech and Astellas leveraged the Sepasoft Batch Procedure Module for complex bioprocess workflows beyond typical implementations. During development, they identified and resolved approximately 20 system-level improvements through collaboration with Sepasoft engineers, strengthening the platform for life sciences applications.

Solution

E Tech Group and Astellas partnered to implement a centralized Ignition architecture that unified eight bioreactors across two production trains into a single operational interface.

Ignition as the Supervisory Platform

Ignition serves as the central SCADA and orchestration layer, integrating reactor data through OPC UA connectivity. This architecture enables real-time monitoring, centralized batch execution, and scalable integration of future equipment.

Standardized Ignition Library

To ensure scalability and maintainability, E Tech Group developed a validated Ignition standards library, including ISA-88-aligned control module and equipment module UDTs:

• Reusable graphical faceplates
• P&ID process mimics
• Alarm and event dashboards
• Historian visualization templates

This modular architecture allows Astellas to rapidly expand to accommodate additional reactors or unit operations.

Centralized Recipe and Batch Execution

Using the Sepasoft Batch Procedure Module, E Tech implemented a single master recipe architecture supporting multiple reactor sizes (50–1,000L). E Tech migrated batch execution from local reactor systems to Ignition, enabling:

• Centralized recipe management
• Batch step visualization
• Automated batch reporting
• Secure electronic signatures

Operator Experience

E Tech designed Ignition Perspective screens to provide intuitive plant-wide visibility, including:

• Multi-reactor overview dashboards
• Real-time batch monitoring screens
• Alarm and event summaries
• Integrated batch record viewers

Operators can now monitor and control all eight reactors simultaneously from a single interface.

Data and Historian Integration

The Ignition system streams process data to AVEVA PI Historian, enabling long-term data analysis and preparing the facility for advanced manufacturing intelligence initiatives.

Result

The Ignition-based solution delivered measurable improvements in operational efficiency, scalability, and regulatory readiness.

Unified Operational Visibility

Operators can now monitor all eight bioreactors simultaneously, eliminating fragmented views across multiple OEM interfaces.

Faster Batch Review and Release

The solution’s centralized electronic batch records and automated audit trails have significantly reduced manual documentation review cycles required for batch release.

Improved Recipe Governance

A single master recipe framework ensures consistent execution across multiple reactor sizes, reducing configuration errors and simplifying process updates.

Increased Operational Efficiency

With centralized monitoring and batch control, fewer operators are required to oversee multiple reactors, enabling engineering teams to focus on process optimization.

Scalable Digital Architecture

Ignition’s supervisory layer is independent of the underlying OEM control systems, so the architecture can easily integrate additional equipment from other vendors without reengineering the system.

Foundation for Manufacturing Intelligence

The project established a digital infrastructure that enables Astellas to expand into:

• Advanced analytics
• Process optimization
• Cross-unit process visibility

This project avoided costly OEM retrofits by introducing an enterprise‑ready digital backbone that positions Astellas for long‑term expansion. It demonstrates how Ignition can transform proprietary OEM equipment into an open, scalable manufacturing platform purpose‑built for regulated life sciences environments.

Rather than replacing the existing bioreactor control systems, Astellas implemented Ignition as a supervisory orchestration layer, integrating eight OEM bioreactors through OPC UA and enabling centralized batch execution using Sepasoft’s Batch Procedure Module. This approach preserved validated OEM control logic while introducing modern capabilities such as unified batch monitoring, centralized recipe management, and electronic batch records. The solution also established a validated, reusable Ignition standards library aligned with ISA-88 batch models, enabling rapid deployment for future bioreactor systems and other process units.

By combining open industrial technologies with rigorous 21 CFR Part 11-compliance requirements, the project illustrates how Ignition can serve as a true digital backbone for biopharmaceutical manufacturing. It unifies traditionally isolated biotech systems into a compliant, scalable, and analytics-ready platform, setting a new benchmark for digital transformation in gene therapy production.

Project Team

E Tech:

• Wayne Hansley – Account Manager
• Chirag Savaliya – Team Lead (Ignition and Sepasoft SME)
• Daniel Ward – Ignition UX Lead
• Stephanie Simmons – E Tech Quality Lead – GMP Compliance
• Shelby Widener – E Tech Quality Control – Documentation and Compliance
• Pat Nocera – Application Testing Lead
• Pradeep Paul – Technical Consultant

Astellas:

• Claire Weber – Site Automation Lead
• Kevin Reid Swann – Project Lead

Project Scope

• Start Date: 05/2025

• Deploy Date: 10/2025

• Tags: 50,000

• Screens: 30+

• Clients: 10+

• Alarms: 10,000+

• Devices: 8 PLCs

• Architecture: Standard with redundancy

• Databases: Ignition and Sepasoft databases

• Historical data logged: Data provider to AVEVA PI

• Number of people on team: 10

• Ignition Ecosystem: Sepasoft