An Environmental Life Cycle Assessment Comparison of Single-Use and Conventional Process Technology for Biopharmaceutical Development and Manufacturing

Biopharmaceutical development and manufacturing require scalable processes that can be quickly developed, easily implemented, and smoothly transferred to production. The use of single-use technologies within the biopharmaceutical industry continues to increase as these technologies provide important flexibility for bioprocessing. Meanwhile the world continues to face mounting pressure related to a variety of environmental concerns including climate, water scarcity, and other resource availability issues. Rapid shifts in technology or technology adoption present an opportunity, and an obligation, to evaluate sustainability implications.

We will present comparative studies of the environmental impacts of producing monoclonal antibodies using either single-use or traditional process technology. The studies are based on Life cycle assessment (LCA) methodology. LCA considers environmental impacts across the entire life cycle of each process component, from material extraction and refining through component manufacturing, packaging, distribution, use, and disposal at end-of-life.

The results from the first study indicate that the single-use process train exhibits lower environmental impacts compared to the traditional process train, primarily due to a reduced need for large amounts of energy-intensive water-for-injection, process water, and clean steam. In the second study a more detailed investigation is performed, with some of the latest single-use technologies. A variety of end-of-life treatment options for single-use components is assessed. Implementation of single-use process technology in existing facilities as well as in standalone turnkey facilities in multiple global regions will be explored.