Environmental sustainability assessment of the manufacturing process of a biological active pharmaceutical ingredient

Abstract

BACKGROUND Although the biopharmaceutical market grows rapidly, the environmental impacts of biopharmaceutical manufacturing have been hardly evaluated. The aim of the study is to comprehensively assess the environmental sustainability of a biologically‐produced active pharmaceutical ingredient (API) manufacturing process. For this purpose, an exergy analysis and an (exergetic) life cycle assessment were performed using primary (foreground system) and modeled data (background system). Infliximab, a monoclonal antibody, was considered. RESULTS The fermentation and its raw materials' supply chain was determined to have the highest environmental impact, since the culture media requires chemicals and complex compounds such as animal‐derived materials (ADMs). The total impact per 100 mg of API produced ranged between 18.6 and 101.8 MJex and 2.0–3.1 kg CO2‐eq, mainly as a function of the ADMs' source. A comparison of infliximab and ustekinumab, a biopharmaceutical produced without ADMs, showed that eliminating these materials can reduce the cumulative resource consumption of monoclonal antibody manufacturing by up to 7.5 times. The fermentation is the process taking the longest and the heating, ventilation and air conditioning system which support fermentation areas consumes approximately 75% of all plant electricity use. CONCLUSIONS Culture media nutrients and cleanroom requirements are driving factors in the environmental impact of biological API manufacturing. Obtaining more precise data of the bioprocesses behind these nutrients' supply chain is crucial to corroborating this study's results. © 2019 Society of Chemical Industry

Environmental impacts associated with the manufacturing of personalised medicines: a scoping review

“…These articles were heterogeneous. One article focused on conducting an environmental impact assessment of a specific monoclonal antibody using a life cycle assessment approach (antibodies included infliximab and ustekinumab) (86). In contrast, seven articles focused on assessing the manufacturing processes associated with monoclonal antibodies in general.…”

“…While one study highlighted water use during the sterilisation of multi-use equipment as a key contributor to environmental impacts of monoclonal antibody manufacturing (92), another study showed how the alternative-single use technologies/equipment production-were associated with electricity consumption, freshwater use, emissions, human toxicity non-cancer effects, and photochemical ozone formation (87). Compounding this heterogeneity of approaches, Gamiz et al (2019) pointed to the uncertainties associated with conducting LCAs given current data gaps in the supply chain of these production processes (86).…”

Model development and energy and exergy analysis of the biomass gasification process (Based on the various biomass sources)

“…La información para el cálculo de exergía para cultivos es un poco limitada, ya que requiere de cálculos avanzados en el área de la biología y análisis del comportamiento energético en el interior de la célula [173]. Además de esto el acceso a la información correspondiente a la composición de las plantas en cada etapa de su crecimiento es limitado o nula, por lo que se vuelve imprescindible realizar suposiciones en algunas de las etapas para el cálculo de la exergía química de las corrientes.…”

“…Rentería Gamiz et al [131] en el año 2019, evalúan la sostenibilidad ambiental de un proceso de manufactura de ingredientes activos para la industria farmacéutica, mediante la aplicación de análisis exergéticos y LCA. Por otro lado, Un análisis de exergía es aplicado en conjunto al LCA sobre un proceso de producción de cemento para evaluar el costo real ecológico de una de las industrias más energéticamente intensivas y con altas emisiones de CO2 [132].…”

Technical Potential for Energy and GWP Reduction in Chemical–Pharmaceutical Industry in Germany and EU—Focused on Biologics and Botanicals Manufacturing

“…In many studies, the energy demand and environmental impact of biologics manufacturing have been evaluated by life cycle assessment; water for injection (WFI) has consistently been identified as a key factor [47][48][49][50][51][52][53][54]. While they are mostly used for chromatographic steps, typical product-specific volumes of cleaning-in-place (CIP) and sterilizing-in-place (SIP) are in the range of 4-20 m 3 WFI /kg mAb [48,50,[55][56][57][58]. Idris et al showed that, for a large-scale 20 m 3 mAb process (titer 2 g/L), 1.9 m 3 WFI /kg mAb is used just for Protein A chromatography [50].…”