(465f) Applying Economic Analysis in the Evaluation of Batch Versus Continuous Manufacturing for Oral Solid Dosage Forms

Up to now, the introduction of continuous manufacturing in the pharmaceutical industry has been discussed with a strong focus on technological aspects and advantages. This is due to the significant technological and scientific challenges faced in moving from isolated end-point-driven unit operations, and their straight-forward batch definition, to semi-continuous or even plug flow approaches. In addition, the commercial availability of integrated continuous manufacturing lines is currently still limited, as is the operational experience with these lines. These technological and scientific challenges are currently addressed by various research groups in academia, as well as by the pharmaceutical and equipment engineering industry.

Looking just a few years into the future, different continuous manufacturing lines will be readily available from pharmaceutical equipment vendors. Pharmaceutical companies, on the other hand, will have gained operational experience in commercial manufacturing operations with these lines. The question whether or not to apply a continuous or a batch-based manufacturing approach will then be answered by the actual process requirements, as well as the associated economic dimension in terms of cost of goods manufactured. The selection of the technological manufacturing approach will then be less of a choice between a more traditional (batch-based) and a more innovative (continuous) approach, but more of a holistic techno-economic optimization exercise.

Based on the experience of previous and ongoing continuous manufacturing development projects, a general methodology of how to include an economic analysis into a pharmaceutical process selection is presented. Possibilities and limitations of the methodology are introduced with a conceptual process evaluation example dealing with secondary manufacturing of an oral solid dosage form. Implications on the relevance of continuous processes in future pharmaceutical manufacturing operations are briefly discussed.