Case Study: ImClone Systems achieves world-class lean manufacturing and real-time process insights with TIBCO Software (S-PLUS Enterprise Server)

ImClone Builds World Class Lean Manufacturing System

ImClone Systems, a biopharmaceutical company known for oncology treatments such as ERBITUX, faced the challenge of building a world‑class lean manufacturing facility while developing a cost‑effective data and information system in parallel. The company needed analytics built into the system from the start to meet Quality by Design principles and CFR Part 11 regulatory requirements, and to gain actionable insight into a complex production process.

ImClone implemented Insightful’s S‑PLUS Enterprise Server to integrate manufacturing, quality and ERP data streams, providing rapid development, scalable processing and intuitive interfaces. The platform delivered real‑time access for 100+ users, end‑to‑end monitoring of thousands of data points per batch, standardized regulatory reports and rich visualizations—enabling faster decision‑making, bottleneck identification, measurable quality improvements and greater cost efficiency.

ImClone Systems

Anthony Lonardo

Senior Director of Statistics and Quantitative Sciences