Olivier Dapremont
AMPAC Fine Chemicals LLC, USA
Title: Implementation of a continuous chromatographic process for the manufacturing of an API
Biography
Biography: Olivier Dapremont
Abstract
The advantages of continuous processing for commercial scale manufacturing are well known and accepted in many industries; reduction in the manufacturing footprint, increase in process safety, increased automation, reduction in manpower requirements, better economics are some of the known advantages. However, implementing a continuous process in an industry that is traditionally batch is often challenging. The regulatory aspects are certainly the most difficult to overcome as a shift in the approach to validation, process monitoring and even “batch” documentation is required to adapt to the specificity of the continuous nature of the process. The author will discuss the various aspects of the successful implementation of a continuous chromatographic process for the manufacturing of an API at commercial scale through actual examples.