Formulation Process Optimization

Abstract

The field of biologics drugs development continues to grow and is becoming increasingly competitive. The manufacturing of biological medicines is a complex process that consumes a large amount of resources and time resulting in higher manufacturing costs in comparison of small molecules therapies. The lean manufacturing philosophy provides tools to identify areas of opportunity to optimize these processes by eliminating waste as activities that does not add value to the product. Buffer formulation is an inherent step in the biological product formulation process. Using the Value Stream Map tool in our buffer formulation process helped to find areas of opportunity that will allow recommendations to optimize the formulation process. In this way, it is possible to reduce manufacturing costs, increase capacity and have a better allocation of resources. Key Terms - Biologic Drugs, Buffer, Formulation, Lean Manufacturing, Value Stream Map.