Raw Material Optimization to Bend the Biopharmaceutical Cost Curve

Abstract

Raw materials sourced from sole third-party suppliers have been identified as one of the key risks to Amgen’s operation. This project aims to reduce raw material costs through sourcing alternative materials and optimizing material consumption.

To systematically evaluate alternative material supply, a cross-functional assessment framework consolidating qualitative and quantitative inputs with flexibility option analysis for uncertainties is established. Case studies are conducted on a chromatography resin and a cell culture media constituent, both of which are currently sourced from single channel. To optimize raw material consumption, an integrated biomanufacturing process and material cost model is developed to provide recommendations on the process parameters and the use of raw materials. The optimization model incorporates equipment capacity constraints as well as material consumption across all stages of drug substance manufacturing. The model is applied to the development of a next-generation process for a commercial molecule and identifies process operating conditions where the raw material costs can be reduced while maximizing productivity. Sensitivity analyses are conducted to understand the impact of uncertainties to materials costs and process yields. Material cost sensitivity analysis reveals the importance of material order planning and alternative material opportunities.

Overall, the project adopts a systematic approach to reduce costs and mitigate raw material risks at an early stage of the biopharmaceutical product life cycle.