ImClone, a wholly-owned subsidiary of Eli Lilly, is a leader in the research, development and manufacturing of oncology drugs. The manufacture of pharmaceutical products is a complex process requiring multiple validation checks necessary to ensure patients get a safe and efficacious product.
Prior to implementing STARLIMS and STARLIMS SDMS in 2010, the ImClone testing laboratory utilized an entirely paper based system to track and manage test results but soon ImClone was forecasting tremendous growth in manufacturing, which would result in increasing demand on the testing department. The paper based process was difficult to scale to accommodate the increased volume and presented several challenges. First, processing paper is resource intensive and slows down turnaround time. In addition, paper makes it difficult for the lab to continue scaling up in response to the increased volume of manufacturing, without adding additional headcount. Finally, a paper process increases the risk of samples not getting tested properly, or being unnecessarily retested.
To fix this issues, ImClone initiated a process to select a new automated Laboratory Information Management System (LIMS). After a thorough decision review process, ImClone selected STARLIMS and the STARLIMS Scientific Data Management System (SDMS) as best meeting its needs. STARLIMS offered a web based LIMS solution which would allow the automation of sample receipt and tracking throughout the laboratory process. In addition, the tight, seamless integration between STARLIMS and STARLIMS SDMS allows the centrally administered LIMS solution to process all types of data generated by instruments.