Tuesday, August 12, 2008 - 9:00 AM
S62

Tech Transfer Comparisons of a Fixed Process versus an Early Stage Project

Blair McNeill, Upstream Development, Cook Pharmica, LLC, 1300 S. Patterson Dr., PO Box 970, Bloomington, IN 47402

Technology transfer is a complex process of moving information and a process from one organization to another. This can occur between companies or within a company, each having their own complexities. Complicating these communication lines is the state of a process. A late stage process typically is fixed, thus has little to no room for change or improvements. This requires in-depth understanding of a client’s process, current equipment the process is executed in, and then making necessary, minor changes to run within the new sites’ equipment. In contrast, an early stage process is minimally defined, typically consisting of the basic process, but little knowledge surrounding operating ranges and process robustness. While both types of transfers are complex and require a high degree of process and equipment understandings, the early stage transfers provide opportunity for the process development scientist to increase process robustness by understanding the design space of an entire process or unit operation. The late stage projects and commercial projects require an understanding of the critical process parameters, critical quality attributes, and proven acceptable ranges for the incoming process and unit operations. This then requires the process scientist to understand the equipment the project will be operated on, and how minimal changes can be made for the process to run consistently from batch to batch.