Streamlined life cycle assessment of single use technologies in biopharmaceutical manufacture

• Published in: New biotechnology 2022-05, Vol.68, p.28-36
• Main Authors: Budzinski, Kristi, Constable, David, D’Aquila, Daniel, Smith, Phillip, Madabhushi, Sri R., Whiting, Andy, Costelloe, Tom, Collins, Michael
• Format: Article
• Language: English
• Subjects: Animals; Biological Products; Biologics; Environment; Life cycle assessment; Life Cycle Stages; Monoclonal antibody; Process intensification; Single use technology
• ISSN: 1871-6784; 1876-4347
• DOI: 10.1016/j.nbt.2022.01.002

•Life cycle assessment was performed for a generic monoclonal antibody single use manufacturing process.•The global warming potential for a US-based 2000 L process was shown to be 22.7 tons CO2eq per 1 kg drug substance.•The use phase contributes the majority of the environmental impact.•Biologics manufacturers have the biggest opportunity to reduce environmental impact.•Process intensification and plant utilization are key to reducing environmental impact. The rapid growth of biologics as the preferred modality in several therapeutic areas has led to changes in the environmental profile of pharmaceutical manufacturing for some companies. The increased use of single use technologies (SUT) in biologics manufacturing has been accompanied by a greater public awareness of plastics waste, but the full life cycle environmental impacts of SUT have had limited study. Therefore, a segment of American Chemical Society Green Chemistry Institute Pharmaceutical Roundtable member companies undertook a streamlined cradle-to-gate life cycle assessment on a biological bulk drug substance (BDS) manufacturing process utilizing SUT at the 2000 L scale. The goal of this study was to highlight where pharmaceutical companies, and biologics producers in particular, can reduce the environmental impact of their drug substance manufacturing. The results have shown that the largest contribution to the life cycle environmental impact for SUT was found to be the electricity used to operate the plant. Interestingly, across all impact categories, the contribution to the environmental footprint from end-of-life due to the use of plastic SUT was extremely small. Although not quantified in this study, these findings and others suggest operational changes that increase process efficiency and decrease time in plant are among the best strategies for reducing the life cycle environmental impact of biologics manufacturing.