Rapid scale-up of pharmaceutical processes- Finding the tr..

An approach is presented for the management of knowledge gained during the development of pharmaceutical processes. The “Toolbox” approach risk-manages resource commitments during process development by ensuring that knowledge of processing characteristics increases in-line with increasing product maturity. The “Toolboxes” provide an introduction to the basic principles for the novice. This is combined with common laboratory equipment and experimental methodologies to provide a lingua franca for engineers working on chemical processes across international borders. Finally, pre-constructed mathematical models have been created to remove the duplication of effort inherent in building and validating scale-up calculations.