Data-based tiered approach for improving pharmaceutical batch production processes

Abstract

Enhancing yield in production is paramount for success in the increasingly competitive pharmaceutical industry, especially for manufacturers of costly biopharmaceutical products. Effort and complexity of implementing enhancements are forcing decision makers to first identify and quantify potentials and opportunities and then trigger process reviews efficiently. Data for supporting such quantifications have been traditionally recorded in the industry; the trend towards better accessibility of production data now facilitates consulting them and the need for developing appropriate tools gets evident. We present a four-level approach to convert production data into serviceable information, supporting the prioritization of processes and assisting real-life changes based on information from analysing production conditions. The approach was applied at a drug product manufacturing plant on a sample of 43 batches; main loss causes were identified and quantified. The three dominant loss sources account for nearly two-third of losses and are largely batch-size independent.