In the News

The Situation: A biotech company specializing in cell therapy was growing rapidly with a critical need to scale its IT infrastructure to support the business. The personalized medicine immunotherapy space is delivering a relatively new therapy platform. Manufacturing processes are rapidly evolving and the process has some unique characteristics and challenges. The concept of one batch being made to order for one patient means one set of batch records for each patient and the number of batch records and data needing to be managed can multiply rapidly even during the clinical trials phase when trials of only 50 to 100 patients are being run.