Many biopharmaceutical companies have replaced or are planning to replace traditional multi-use process equipment (fixed-in-place stainless-steel fermenters, tanks, downstream processing equipment, and associated piping) with single-use systems to improve flexibility, productivity, and cost (1–3). The use of disposable components reduces or eliminates the need for extensive cleaning and steam sterilization between batches. However, single-use process technologies can also have negative environmental impacts because they involve the use and disposal of consumable materials.
Several previous studies have looked at environmental impacts of single use biopharmaceutical manufacturing technologies (4–7). To further understand the balance of environmental impacts, GE Healthcare in collaboration with GE's Ecoassessment Center of Excellence has completed an extensive study of the life-cycle environmental impacts of the full process train required to produce monoclonal antibodies (mAbs). The study compares the use of single-use versus traditional durable process technologies at 100-L, 500-L, and 2000-L scales. The scales were chosen to reflect the clinical phase, the scale-up phase, and the final production phase. Process data were derived in collaboration with BioPharm Services, developer of BioSolve, an industry-standard bioprocess model that can be used to build any process including those for manufacture of mAbs, vaccines, and bacterial-based products.
This comprehensive environmental study of single-use process technology is the first to offer a comprehensive examination of environmental impacts across the full process train using life cycle assessment (LCA). LCA is an internationally recognized discipline that can be used to examine products and processes from an environmental perspective across the full lifecycle of a product or process, from raw-material extraction and refining through manufacturing, use, and end-of-life disposal or recycling. The methods involve analyzing material and energy flows from cradle-to-grave to calculate potential environmental impacts. This study was performed in accordance with the International Standards Organization ISO 14040 and ISO 14044 (8, 9). The details and quality of the study were evaluated by a third-party critical review panel as per ISO 14044 because the study involved comparative assertions. The critical review panel consisted of an independent LCA expert and two domain experts from the biopharmaceutical manufacturing industry (10).The results reported here focus on global warming potential (i.e., greenhouse gas emissions), cumulative energy demand (i.e., embodied energy), and water usage. The study also examined a range of additional environmental impact categories, such as ozone depletion, acidification, eutrophication, resource depletion, particulate matter formation, photochemical oxidant formation, as well as others. A companion article describing the results of the more comprehensive set of environmental impact categories is in preparation and will be published separately.