Abstract

Process optimization, in essence, consists of evaluating a process workflow for improvement purposes by effectively utilizing available resources. This paper aims to focus on the Biologics Final Drug Product (FDP) manufacturing process with regard to exploring the nuances of the standard methodology and gauge how it can be more streamlined to achieve more efficient manufacturing outcomes. This is achieved by performing a comprehensive exploration of FDP Manufacturing industry strategies alluding to deviations and management of rejects, risk level analysis, as well as automated systems & reducing human intervention to attain a holistic understanding for varied elements of FDP manufacturing and identify potential improvements to drive more optimal results with the same set of resources in this rapidly evolving market.

Keywords

final drug product, biologics, process optimization, deviation, secondary packaging, automated process, ancillary kit