Case Study: From Groundbreaking to Regulatory Approval in 26 Months
One leading biotech manufacturer. Eight production lines. One goal. The fastest facility build in company history.
#situation
The Situation: Scaling a Facility with No Room for Delay
The new production plant was designed to meet surging global demand for final product assembly and packaging. But ambition alone doesn’t build a plant. The team needed a SCADA system that could unify eight production lines, each running automation equipment from different OEM vendors, including Rockwell, Siemens, B&R, and others, into a single, centralized supervisory environment.
This wasn’t a simple integration job. It was a greenfield site, an aggressive qualification schedule, and a zero-tolerance regulatory environment. Every decision carried real consequences.
The Challenge: Complexity at Every Layer
Most SCADA deployments are designed around individual machines or single production lines. This project demanded something entirely different — a platform capable of delivering:
- Centralized visibility across all eight packaging lines simultaneously
- Real-time data acquisition, process monitoring, and interlock management from heterogeneous automation systems
- Seamless integration with MES, Data Historian, Serialization, and AWS-hosted AI applications
- Batch management for recipe selection, configuration, and execution
- A validated, modular architecture that could meet FDA standards on an accelerated timeline
Every layer of the operation had to talk to every other layer. And the team had to get it right quickly and compliantly.
The full scope of how Orise designed, deployed, and validated this solution, including the specific architecture decisions, integration approach, and qualification strategy, is detailed in the full case study.
#solution
The Orise Solution: A New Benchmark for Biotech Manufacturing The numbers tell a clear story. But the implications go further.
26 months. From groundbreaking to FDA approval — the fastest site startup in the company’s history.
Here’s what the Orise-implemented SCADA platform delivered:
- Complete line-level visibility: Real-time monitoring of individual machine performance and total yield across all eight lines
- Faster qualification cycles: Standardized, reusable modules shortened validation timelines significantly
- Reduced downtime: Early alerts and automated responses kept production moving
- AI-enabled efficiency: Integration with AWS-based applications accelerated line clearance and enabled predictive maintenance
- Measurable cost savings: Improved process control reduced energy consumption, waste, and manual errors compared to similar facilities
The project’s success was so significant that the same SCADA architecture is now being replicated at additional sites, including a six-line expansion of the same U.S. facility.
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See Exactly How it Was Done
The architecture that made this possible. The integration decisions that kept the project on schedule. The validation approach that satisfied the FDA. It’s all in the case study below.