The goal of this study was to compare the potential environmental impacts associated with the production of mAbs using either
single-use or traditional durable process technologies. The full process trains were evaluated at 100-L, 500-L, and 2000-L
scales. Calculations were based on a 10-batch campaign assuming 6 g/L titres. The study did not account for any potential
difference in product yield resulting from choice of process technology. Any such issues are product- or process-specific
and beyond the scope of this study.
The results of this LCA will be used to communicate potential environmental impacts to interested stakeholders and to identify
key areas for potential improvement in terms of supply chain, product design, manufacturing, or end-of-life as appropriate.
The scope of this study included both upstream and downstream processes involved in the production of mAbs. Figure 1 shows
a process schematic of the full process train categorized into fourteen unit operations. A 15th category included the clean-in-place/steam-in-place (CIP/SIP) infrastructure and common support activities, such as process
water and HVAC requirements (collectively termed "Support CIP/SIP System").
Figure 1: Process diagram of full process train for the production of monoclonal antibodies (mAbs). For this study, the process
train was categorized into 14 unit operations and a 15th category, "Support CIP/SIP System," that included the clean-in-place/steam-in-place
infrastructure and common support activities, such as process water and HVAC requirements. IEX is ion-exchange chromatography,
UF/DF is ultrafiltration/diafiltration.
The potential for a smaller production facility enabled by the choice of single-use technology was not specifically included
in the scope of this study. However, the floor space used per HVAC class for each technology was scaled to the required facility
footprint. This approach assumed that a traditional technology facility is in place and single-use technology is adapted to
the existing facility.
A variety of single-use technology from different manufacturers is available. This study systematically used GE technology
(i.e., WAVE Bioreactor system and ReadyToProcess components) wherever appropriate due to the greater availability of internal
data, and to support an effort to identify opportunities for environmentally conscious product design.
This study did not address any potential differences in labor requirements.
Life-cycle inventory analysis
The main body of data used in this study was derived in collaboration with BioPharm Services and can be considered industry
average based on a combination of primary and secondary sources. Data on production of single-use components were obtained
primarily from GE Healthcare. Data on transportation, packaging, and end-of-life were gathered through a combination of supplier
data (GE Healthcare) and expert interviews. Additional secondary data were obtained from the ecoinvent 2.2 life-cycle inventory
The life-cycle assessment models were developed in SimaPro Analyst version 7.2.4 life-cycle assessment software (12). The
inventory data were analyzed using several impact assessment methodologies. Cumulative energy demand (CED) was calculated
using the Cumulative Energy Demand v1.07 method and includes the total life cycle energy requirements including production
and distribution of energy that is consumed across the life cycle, reported in units of megajoule-equivalents (MJ-eq). Lifecycle
global warming potential (GWP) was calculated using the IPCC 2007 100a method and is reported as CO2-equivalents (CO2-eq), including all greenhouse gases specified in the Kyoto Protocol using 100-year time horizon global warming potentials from the Intergovernmental Panel on Climate Change 4th Assessment Report
(13). Water usage (withdrawal) is reported in kilograms (kg) and was calculated using a custom impact assessment method that
evaluates the withdrawal of freshwater (and saltwater, if any) across the lifecycle of the system being studied.