Case Study
The challenge:
A clinical and commercial gene-therapy manufacturer relied on fragmented batch records and manual review across multiple systems, slowing batch release and adding validation risk as new products and sites came online.
Stellix’s role:
Our team acted as a neutral MES architect, designing and implementing a hybrid MES that integrated electronic batch records with IoT and analytics, rather than forcing a single monolothic platform.
The outcome:
Batch review times dropped by 40%, with real-time compliance monitoring and smoother tech transfer across the product lifecycle, turning MES from a documentation bottleneck into an enabler of faster, compliant release.
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