The Business Case for Process Analytical Technology (PAT) -A Starting Point

摘要

The presentation of a new Process Analytical Technology (PAT) application to a pharmaceutical company is often followed by the question: "But what is the business case?" or request: "A stronger business case is needed", or "The business case has to be clear". The pharmaceutical scientist is often unprepared for this question and is only prepared to explain scientific/technological issues: the design of experiments proposed for process understanding and how a PAT method works. The scientist has studied the process thoroughly and is ready to explain the critical process parameter that is being monitored, the frequency with which measurements would be obtained, and possible control options. As the PAT methods are not easy to explain or understand, the scientist is often completely focused on the scientific aspects, and not the business case. The implementation of PAT will require a Capital Investment Project because it is often a large scale, long-term project and represents a large investment in time, personnel and overall resources, hence the importance of a well-structured business case. The approval of the capital project may take a year or more depending on the company and the complexity of the project. However, very few articles have addressed the importance of developing a strong business case to advance PAT implementation in industry.12