Valent BioSciences + Leucine
Transforming paper batch records into data-driven operational efficiency at the world's largest purpose-built biorational manufacturing facility.
“Digitising records lets you use analytics to correct issues and capture opportunities sooner, so you can accelerate your growth. Leucine MES is the interface we want our operators looking at — the UX is that good.”
Digital Transformation Lead
Valent BioSciences
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Challenge
Valent BioSciences is a global leader in the development and commercialisation of biorational technologies — products manufactured through proprietary fermentation processes rooted in pharmaceutical manufacturing techniques that the company has been perfecting for more than 50 years. A subsidiary of Sumitomo Chemical, Valent BioSciences operates state-of-the-art manufacturing facilities including its flagship $146 million plant in Osage, Iowa — the largest purpose-built biorational product facility in the world.
At the Osage facility, production processes involve detailed steps and precise measurements — much like pharmaceutical manufacturing at scale. Every batch requires careful documentation: raw material inputs, fermentation parameters, process timings, quality control checks, and final product specifications. Plant staff manually recorded everything through paper batch records, validating each step along the way.
As the company grew, the paper-based system became a bottleneck that constrained operations at every level. Reviewing and approving batch records took up to 20 days per batch. Reporting and investigations required slow, manual workflows that pulled staff away from production. Root-cause analyses were difficult without accessible historical data — finding information meant physically tracking down binders somewhere in the plant. QC lab staff alone spent two hours per day just printing records.
The problems extended beyond time. Paper records were vulnerable to damage, loss, and illegible handwriting. There was no way to enforce correct workflow sequencing — steps could be completed out of order without the system catching it. And because all data lived on paper, there was no ability to aggregate production data across batches, identify trends, or drive data-informed decisions about quality and capacity.
Plant leadership recognised that the operational ceiling was not their equipment or their people — it was the inability to access and act on their own production data. With significant demand for their products and a world-class facility capable of producing more, the question became urgent: how do you exploit capacity when your record-keeping system is the constraint?
- ↪ How do you reduce batch review from 20 days when every record is a physical paper document?
- ↪ How do you perform root-cause analysis without searchable, accessible historical data?
- ↪ How do you build quality into workflows rather than checking for it after the fact?
- ↪ How do you exploit manufacturing capacity when documentation is the bottleneck?
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Solution
The implementation began in the Osage facility's quality control lab — the area with the most acute paper burden, where staff were spending two hours every day just printing records. Leucine MES was deployed to digitise core QC workflows first, replacing paper forms with structured digital records that staff could complete on tablets in real time as they worked. The improvement was immediate and visible: processes that had been slow and paper-heavy became faster and smoother, with typed, validated entries replacing handwritten notes.
Based on the success in the QC lab, the project expanded to tackle the facility's full electronic batch record (EBR) initiative. The team scoped the configuration of all 52 production processes at the Osage plant — mapping each one from raw material input through fermentation, product recovery, quality checks, and final release. Each process was configured in Leucine MES with built-in workflow sequencing, validation rules, and electronic signatures to ensure compliance and data integrity at every step.
The implementation was driven by close collaboration between the Leucine MES team and Valent BioSciences' plant operations, quality, and IT teams. Dedicated project resources and regular meetings kept all teams aligned. When integration with the facility's plant intelligence (PI) system required cross-team coordination, the Leucine MES team was flexible and responsive — scheduling as many meetings as needed to provide clarity and ensure seamless data flow between systems.
A key factor in the project's success was responsiveness to user feedback. As operators and supervisors began using the system on the production floor, their feedback was captured and acted on quickly. Configuration adjustments and customisations were turned around rapidly, building confidence across the plant that the digital system was being shaped to fit their workflows — not the other way around.
The rollout followed a phased approach: of the 52 configured processes, 30 were shifted to fully paperless operation in the initial deployment, with the remaining processes being transitioned progressively. The facility now operates with tablets running Leucine MES across the production floor, giving staff the ability to record information in real time as they complete each step — replacing the old cycle of completing work, then going back to fill in paper records after the fact.
With the core EBR digitisation complete, the plant is now expanding its use of Leucine MES by integrating the full range of automatic sensor data from plant equipment through the PI system. This integration will enable real-time monitoring and alerting — allowing operators and managers to see what's happening across the plant in real time, identify issues before they become deviations, and systematically improve overall equipment effectiveness.
See the batch review & release use case03 /
Impact
20→1
Batch review and reconciliation reduced from 20 days to 1 day
1,800
Batches processed through the digital platform
60%
Reduction in manual data entries across production workflows
2,700
Hours saved annually on documentation at the Osage facility
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Leucine MES
The Manufacturing Execution System that transformed Valent BioSciences' paper batch records into structured, searchable, real-time digital workflows — driving a 20x acceleration in batch review and saving thousands of hours annually.
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