Life‐cycle and cost of goods assessment of fed‐batch and perfusion‐based manufacturing processes for mAbs

TLDR

Life‑cycle assessment (LCA) quantifies environmental impacts such as water, energy, and waste, but its use in bioprocessing remains limited. The study aims to design a more cost‑efficient, robust, and environmentally friendly mAb manufacturing process by integrating LCA, economic analysis, sensitivity analysis, and scale‑up. The authors evaluate this framework through a comparative analysis of fed‑batch and perfusion upstream configurations, assessing their environmental and economic performance. The framework shows that a standard 4‑day perfusion process has similar cost of goods to fed‑batch but a 35 % higher water use, 17 % higher energy use, and 17 % higher CO₂ emissions, while extending perfusion pooling to 8 days can reduce its environmental footprint. © 2016 American Institute of Chemical Engineers Biotechnol.

Abstract

Life-cycle assessment (LCA) is an environmental assessment tool that quantifies the environmental impact associated with a product or a process (e.g., water consumption, energy requirements, and solid waste generation). While LCA is a standard approach in many commercial industries, its application has not been exploited widely in the bioprocessing sector. To contribute toward the design of more cost-efficient, robust and environmentally-friendly manufacturing process for monoclonal antibodies (mAbs), a framework consisting of an LCA and economic analysis combined with a sensitivity analysis of manufacturing process parameters and a production scale-up study is presented. The efficiency of the framework is demonstrated using a comparative study of the two most commonly used upstream configurations for mAb manufacture, namely fed-batch (FB) and perfusion-based processes. Results obtained by the framework are presented using a range of visualization tools, and indicate that a standard perfusion process (with a pooling duration of 4 days) has similar cost of goods than a FB process but a larger environmental footprint because it consumed 35% more water, demanded 17% more energy, and emitted 17% more CO2 than the FB process. Water consumption was the most important impact category, especially when scaling-up the processes, as energy was required to produce process water and water-for-injection, while CO2 was emitted from energy generation. The sensitivity analysis revealed that the perfusion process can be made more environmentally-friendly than the FB process if the pooling duration is extended to 8 days. © 2016 American Institute of Chemical Engineers Biotechnol. Prog., 32:1324-1335, 2016.