Tactical planning optimization for campaign scheduling of active pharmaceutical ingredient production based on monoclonal antibodies

Abstract

Monoclonal Antibodies (mAb's) are the fastest growing segment in the biopharmaceutical industry. They are used today as therapeutics and diagnostics for several medical applications, including various types of cancer, rheumatoid arthritis, psoriasis, severe asthma macular degeneration, multiple sclerosis and more. In recent years, industry trends and market pressure have driven pharmaceutical companies to focus efforts on increasing operational efficiency in order to reduce the financial burden associated with drug manufacturing. Consequentially, Novartis Pharma Technical Operations' is currently engaging in efforts to obtain Class "A" Manufacturing Resource Planning (MRP II). This project was chosen to analyze and address the current Integrated Business Planning (IBP) technically and financially by analyzing critical processes, their bottlenecks, and prioritizing improvement opportunities. We focus on tactical planning at the Multiproduct Process Unit at BioPharm Ops. This paper describe the development of a Tactical Planning optimization tool, which implements SuperPro Designerc and ScheduleProC (Intelligen Inc., NJ, USA) for campaign scheduling of active pharmaceutical ingredient production based on mammalian monoclonal antibodies (mAb's). Results have shown great potential benefits for Novartis, including but not limited to: Creating and modifying campaign schedules in hours (not days); increased operational efficiency; Max Run Rate Optimization, cycle time reduction and significant production cost savings; analytic tool to support long-term strategic decisions with the flexibility to address real-time adversity and automated conflict resolving.