An Environmental Life Cycle Assessment Comparison Of Single-use And .

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GE HealthcareLife SciencesAn environmental life cycle assessmentcomparison of single-use and conventionalbioprocessing technology

An environmental life cycle assessmentcomparison of single-use andconventional bioprocessing technologyBiopharmaceutical development and manufacturingdemand scalable processes that can be smoothlytransferred to production. These processes need to bequickly developed and easy to implement. Ready-to-usetechnologies such as the ReadyToProcess platformfrom GE Healthcare Life Sciences play a crucial role inproviding the flexibility to support multiproduct facilitiesand deliver process time savings, allowing for fasterchangeover between products. The ReadyToProcessplatform is a complete suite of preconditioned systemsand accessories for biopharmaceutical production,prepared for immediate use. The platform includes bothsingle-use and reusable products.GE Healthcare is committed to helping our customersevaluate and make decisions based on performanceand environmental criteria for your products. Life CycleAssessment (LCA) is an internationally recognizedmethodology (1, 2) that can be used to examine productsfrom an environmental perspective. The methodology canbe used across the full life cycle of the product, from rawmaterial extraction and refining through manufacturing, use,and end-of-life disposal or recycling (Figure 1). By includingthe impacts throughout the product life cycle, LCA providesa comprehensive view of the potential environmentalimpacts of the product and a more accurate picture of theenvironmental trade-offs and improvement opportunity.ResourcesEnd of ibutionFig 1. Product life cycle.2

Single-use technologies offer an attractive option forbiopharmaceutical manufacturing, but their environmentalimpact needs be considered. This paper documents thefindings of an extensive LCA study comparing single-use andconventional bioprocessing technology for the production ofmonoclonal antibodies (MAbs) (3, 4). The study examines the lifecycle environmental impacts associated with MAb productionat three process scales: 100 L, 500 L, and 2000 L. The resultspresented here focus on the 2000 L production scale, but theoverall comparative conclusions for all three process scaleswere similar. This assessment was conducted according to theISO 14040-14044 standards for comparative LCA (1, 2) andwas independently reviewed by a third-party critical reviewpanel. The results demonstrate that the single-use bioprocesstrain has lower environmental impacts compared to theconventional process train in each environmental impactcategory studied. This paper explains why.AssumptionsAssessing bioprocess technology in detail The study did not address any potential differences in laborrequirements.The LCA study compares the life cycle environmental impactsassociated with the production of MAbs using either single-useor conventional bioprocessing technologies. Calculations werebased on a 10-batch campaign assuming 6 g/L titres. The scopeof the study includes both upstream and downstreamprocesses involved in the production of MAbs. Figure 2 showsa process schematic of the full process train categorizedinto 14 unit operations. An additional category included theclean-in-place/steam-in-place (CIP/SIP) infrastructure andcommon support activities, such as process water and HVACrequirements (collectively labeled ‘Support CIP/SIP System’).The bioprocess data used in this study were developed incollaboration with BioPharm Services Inc. and can be consideredindustry average based on a combination of primary andsecondary sources. Data on production of single-usecomponents were obtained primarily from GE Healthcare.Data on transportation, packaging, and end-of-life were gatheredthrough a combination of supplier data (GE Healthcare) andexpert interviews. Additional secondary data were obtainedfrom the ecoinvent 2.2 life cycle inventory database (5).The study looks at the entire life cycle of the process trains forboth types of bioprocessing technologies, including: Supply chain: materials and manufacturing of all processequipment and consumables required to support a 10-batchMAb campaign, including pre-sterilization of single-usecomponents. Use: all activities that occur during MAb production, includingcleaning and sterilization of conventional equipment betweenbatches. Electricity was assumed to be US average. Fuelmix for generation of water-for-injection (WFI) was 45%fuel oil, 45% natural gas and 10% electricity. End-of-Life: transport to end-of-life treatment, disposalof consumables, and the disposal, re-use, or recycling ofdurable components. For single-use components such ascellbags, filters, and connectors, disposal was assumedto occur by hazardous waste incineration without wasteheat recovery. Non-hazardous waste was sent to landfill orwastewater treatment. The study did not account for any potential differences inproduct yield resulting from choice of process technology.Any such issues are product- or process-specific andbeyond the scope of this study. The potential for a smaller production facility enabled bythe choice of single-use technology was not specificallyincluded in the scope of this study.Impact assessment categoriesImpact assessment methods are used to convert the life cycleinventory data (material, energy, and emissions inputs and/or outputs throughout the products’ life cycles) into a set ofenvironmental impacts. Global warming potential (GWP) wascalculated using the IPCC 2007 100a method and includedall greenhouse gases specified in the Kyoto Protocol (6).Cumulative Energy Demand (CED) expresses both embodiedand process energy that is consumed across the life cycle (7).Water usage (withdrawal) was calculated using a customimpact assessment method that evaluates the withdrawalof freshwater across the life cycle. A comprehensive suiteof midpoint and endpoint environmental impact categoriesfrom the internationally accepted method ReCiPe8 was alsoevaluated. A summary of environmental impact categoriesused in this study is shown in Table 1.Sensitivity and uncertainty analysesThe sensitivity of the LCA results to variations in keyassumptions was extensively analyzed using a PlackettBurman statistical experimental design. Lifetime of durableequipment was varied from 5 to 25 years. Chromatographycolumn lifetimes were varied from 10 to 100 cycles.Transportation distances varied from 5 to 25 miles (local),1000 to 5000 miles (domestic), and 1500 to 7500 miles(international). Different ratios of WFI fuel mixes wereexamined. Durable equipment re-use was varied from 0 to25%. Equipment recycling was varied from 50 to 100%. Co-60irradiation facility parameters were also varied. None of thevariations in key assumptions had a significant effect on thestudy conclusions.3

12N-2 SeedN-1 Seed3Vent Filter4NFFPleatedCell GrowthCell GrowthMedia Prep Media SterilizationClarificationCell Culture5Blending /StorageAir Filtration98Blending /StorageClarificationPool Mixing76pHAdjustmentSterileFiltration1110Virus FiltrationBlending /StorageAdjustment /ConcentrationStorageKey1.2.3.4.5.6.7.8.9.N-2 SeedN-1 SeedBioreactorDepth Filtration ClarificationBioburden Reduction IProtein AVirus InactivationBioburden Reduction IINo Tank Bioburden ReductionFig 2. MAb Process flow diagram (courtesy BioPharm Services Inc.).410.11.12.13.14.Capture IEXFlow Through IEXViral FiltrationUF/DFSterile Filtration II Support CIP/SIP SystemSupport CIP/SIP System (not shown)12

Table 1. Environmental impact categories consideredImpact categoryUnitSource methodReferenceGlobal warming potentialkg CO2 eqIPCC 100aIPCC (2007) (6)Cumulative energy demand v 1.08Jungbluth and Frischknecht (2010) (7)ReCiPe Midpoint (H) v 1.07Goedkoop et al. (2009) (8)Cumulative energy demandMJClimate changekg CO2 eqOzone depletionkg CFC-11 eqHuman toxicitykg 1,4-DB eqPhotochemical oxidant formationkg NMVOCParticulate matter formationkg PM10 eqIonizing radiationkg U235 eqTerrestrial acidificationkg SO2 eqFreshwater eutrophicationkg P eqMarine eutrophicationkg N eqTerrestrial ecotoxicitykg 1,4-DB eqFreshwater ecotoxicitykg 1,4-DB eqMarine ecotoxicitykg 1,4-DB eqAgricultural land occupationm2aUrban land occupationm2aNatural land transformationm2Water depletionm3Metal depletionkg Fe eqFossil depletionkg oil eqResultsThe comparative analysis indicates that, based on the dataused and the assumptions made in this study, single-usebioprocessing technology exhibits lower environmentalimpacts compared to conventional bioprocessing technologyin all impact categories studied.7 000 000CED - Single useCED - Conventional6 000 0005 000 0004 000 0003 000 0002 000 0001 000 0000SupplychainUsephaseEndof lifeGlobal Warming Potential [kg CO2eq]Cumulative Energy Demand [MJ]Cumulative energy demand (CED) and global warmingpotential (GWP) for all three life cycle stages (supply chain,use, end-of-life) are shown in Figure 3.400 000350 000GWP - Single useGWP - Conventional300 000250 000 A substantial majority of the impacts occur during theuse stage. The single-use process train exhibits 38% lower GWPduring use and 34% lower GWP across all life cycle stages. The corresponding reduction in CED is 38% during use and32% across all life cycle stages. Supply chain GWP and CED impacts are slightly higher forsingle-use compared to conventional process technologydue to the increased manufacturing required to providethe single-use consumable components. However, supplychain impacts represent 5% of the life cycle GWP impactand 11% of the life cycle CED impact. Environmental impacts from the end-of-life stage are higherfor single-use but represent 1% of overall life cycle impacts.200 000150 000100 00050 0000SupplychainUsephaseEndof lifeFig 3. Cumulative Energy Demand (CED) and Global Warming Potential (GWP)results per life cycle stageSingle-use bioprocessing technology exhibits lowerenvironmental impacts compared to conventionalbioprocessing technology in all impact categories studied.5

3 000 000ConventionalSingle use2 500 0002 000 0001 500 0001 000 000500 0000120 000100 00080 00060 00040 00020 0004 000 0003 000 0002 000 0001 000 entionalSingle use5 000 0000UPSu6 000 000ConventionalSingle use140 000Life Cycle Water Usage [kg]Global Warming Potential [kg CO2eq]160 000Life cycle water usage categorized by unit operation isshown in Figure 6. As expected, water usage is dominated byactivities related to the Support CIP/SIP System. Single-useprocess technology exhibits lower water usage in all unitoperations except Protein A and Ion Exchange chromatography,again due to the need for parallel chromatography columnsat this scale. The negative water usage during the End of Lifestage reflects credit related to the re-use and recycling ofdurable components.UPCumulative Energy Demand [MJ]CED and GWP impacts categorized by unit operation areshown in Figure 4.Fig 4. Cumulative Energy Demand (CED) and Global Warming Potential (GWP)results per unit operationFig 6. Life cycle water usage per unit operation The most substantial impacts (38 to 40% of both GWPand CED) are related to the Support CIP/SIP System, whichincludes the CIP/SIP infrastructure and common supportactivities such as process water and HVAC requirements(the main difference between process approaches in thiscategory is the amount of energy required to generateWFI and steam).A comparison of environmental impacts in all other impactcategories is shown in Figure 7. The single-use bioprocessingtechnology exhibits lower impacts in all impact categoriesstudied. Single-use impacts range from 48 to 85% ofconventional impacts. The use of single-use process technology exhibits lowerCED and GWP impacts compared to conventionaltechnology in all unit operations except Protein A andIon Exchange chromatography, which are higher for thesingle-use process train since several columns must beused in parallel to reach this scale.Water usage categorized by life cycle stage is shown inFigure 5. Substantial water savings are realized during the usestage for single-use process technology due to the reductionor elimination of cleaning and sterilization between batches.Although the results in Figures 3 to 7 focus on the 2000 Lworking volume scale, similar results were obtained at 100 Land 500 L scales. Additional study results and more detaileddiscussions can be found in two recently published articles (3, 4).Life cycle impacts of full process train (2000 L)ReCiPe Midpoint (H)ConventionalSingle Use100%80%60%40%20%0%Life Cycle Water Usage (kg)1 000 000 000ConventionalSingle use800 000 000600 000 000400 000 000Fig 7. Comparison of other environmental impact categories considered.Results represent life cycle impacts of all unit operations in 2000 L scaleprocess train. Single-use impacts are shown relative to conventionalimpacts, which are normalized to 100%.200 000 0000-200 000 000SupplychainUsephaseEndof lifeFig 5. Water usage per life cycle stage6

SummaryGE HealthymaginationThis LCA study shows that a shift from conventional to single-usebioprocessing technology can result in substantial reductionsin global warming potential, cumulative energy demand, waterusage, and other environmental impacts for the productionof monoclonal antibodies. Although single-use bioprocessingtechnology introduces a need for the production, distribution,and disposal of single-use components, this approach alsoreduces or eliminates the need for large quantities of steam,process water and WFI.GE Healthymagination, our 6 billion commitment to globalhealth, invites the world to join us as we continuously developinnovations focused on reducing costs, increasing accessand improving quality around the world. Three years into oursix-year commitment, we have 53 validated products andservices supporting our mission and have touched more than500 000 000 lives.Note that a comparative LCA should not be the sole basisused to determine environmental superiority or equivalence,as additional information may be necessary to overcomesome of the inherent limitations in the life cycle impactassessment. Even if a study has been critically reviewed, theimpact assessment results are relative expressions anddo not predict impacts on category endpoints, thresholdexceedance, or risks. It is further recognized that there areother tools available for environmental assessment suchas risk assessment, environmental impact assessment,and others. LCA was chosen as the best environmental toolto cover the goal and scope of this product comparison.The ability of LCA to consider the entire life cycle of a productmakes it an attractive tool for the comparative assessmentof potential environmental impacts.1. ISO, 2006a, ISO 14040 - Environmental management- life cycle assessment - Principles and framework,International Organisation for Standardization.GE Healthcare’s commitment tosustainabilityAt GE Healthcare, we recognize that being a sustainability leaderis more than creating products that provide environmentaland operating benefits to our customers. GE Healthcareprovides transformational medical technologies and servicesthat are shaping a new age of patient care. There are currentlyover 30 products in the GE Healthcare ecomagination portfolio,providing a range of environmental benefits that include reducingenergy use, greenhouse gases, chemical use, water use andwaste management, while at the same time providingoperating benefits to customers such as improving total costof ownership or clinical efficiency.Our broad expertise in medical imaging and informationtechnologies, medical diagnostics, patient monitoring systems,drug discovery, biopharmaceutical manufacturing technologies,performance improvement and performance solutions serviceshelp our customers to deliver better care to more peoplearound the world at a lower cost. In addition, we partner withhealthcare leaders, striving to leverage the global policy changenecessary to implement a successful shift to sustainablehealthcare systems.References2. ISO, 2006b, ISO 14044 - Environmental management life cycle assessment - Requirements and guidelines,International Organisation for Standardization.3. Pietrzykowski, M., et al. An environmental life-cycleassessment comparing single-use and conventionalprocess technology. BioPharm International, 24, 1-4 (2011).4. Pietrzykowski, M., et al. An environmental life cycleassessment comparison of single-use and conventionalprocess technology for the production of monoclonalantibodies. Journal of Cleaner Production, 41, 150-162 (2013).5. ecoinvent Centre, Swiss Centre for Life Cycle Inventories,Dübendorf (2010).6. IPCC, Climate Change 2007: The Physical Science Basis.Contribution of Working Group I to the Fourth AssessmentReport of the Intergovernmental Panel on ClimateChange, (Solomon, S., et al. Eds.) Cambridge UniversityPress, Cambridge, UK, and New York, USA (2007).7. Jungbluth, N. and Frischknecht, R. Implementation oflife cycle impact assessment methods - Chapter 2:Cumulative Energy Demand. Ecoinvent report No. 3,Swiss Centre for LCI, Dübendorf, CH (2010)8. Goedkoop, M., ReCiPe 2008: A life cycle impactassessment method which comprises harmonisedcategory indicators at the midpoint and the endpoint level.VROM–Ruimte en Milieu, Ministerie van Volkshuisvesting,Ruimtelijke Ordening en Milieubeheer (2009).9. Healthymagination. Available . Ecomagination. Available from:http://www.ge.com/about-us/ecomagination7

ecomaginationThe world’s environmental challengespresent an opportunity for GE to do whatit does best: imagine and build innovativesolutions that benefit our customersand society. Ecomagination representsGE’s commitment to deliver new naturalresource-efficient products and technologiesto market for our customers and society.It is a business initiative to create value byenabling our customers to cut costs, improvequality and reduce environmental impactswhile reducing our own environmentalfootprint at the same time. Ecomaginationis also about our commitment to using ourlimited resources efficiently across the entirelife cycle. Whether it’s the efficient facilitieswhere we design and build our products, orour capabilities for refurbishing or recyclingused equipment in an environmentallyresponsible way, ecomagination benefitsthe communities that we and our customerscollectively serve today and for generationsto come.For local contact information, ces.com/singleuseGE Healthcare Bio-Sciences ABBjörkgatan 30751 84 UppsalaSwedenWAVE Bioreactor GE Healthcare is committed to producingsustainable products that result in significantimprovements in operating and environmentalperformance. One of these products is theWAVE Bioreactor. Using disposable bags ratherthan large stainless steel tanks to producevaccines and other biotherapeutics, theWAVE Bioreactor system enables cell culturingwithout requiring cleaning or steam sterilization,thereby reducing water and energy consumption.In addition, the WAVE Bioreactor also eliminatesthe need for steam to heat and sanitize astainless steel bioreactor, as well as for animpeller to mix the contents of the bioreactor’schamber. This reduces annual energy footprintat the same time. The WAVE Bioreactor, part ofthe ReadyToProcess product line, is included inGE’s ecomagination (10) portfolio.Environmental and operating benefitsThe WAVE Bioreactor eliminates the need forultra-purified water used to sterilize traditionalstainless steel bioreactors. A production facilitythat replaces a stainless steel bioreactor witha GE Healthcare 500 L WAVE Bioreactor systemwith equivalent output can reduce waterconsumption by over 66 000 liters per year—that’s roughly three tanker trucks of ultra-purifiedwater—for savings of more than USD 7300annually at a water cost of USD 0.11 per liter.GE, imagination at work and GE monogram are trademarks of GeneralElectric Company.ReadyToProcess and WAVE Bioreactor are trademarks of trademark ofGE Healthcare companies. 2013 General Electric Company - All rights reserved.First published Nov. 2013.All goods and services are sold subject to the terms and conditions ofsale of the company within GE Healthcare which supplies them. A copyof these terms and conditions is available on request. Contact yourlocal GE Healthcare representative for the most current information.GE Healthcare UK LimitedAmersham PlaceLittle ChalfontBuckinghamshire, HP7 9NAUKGE Healthcare Europe, GmbHMunzinger Strasse 5D-79111 FreiburgGermanyGE Healthcare Bio-Sciences Corp.800 Centennial Avenue, P.O. Box 1327Piscataway, NJ 08855-1327USAGE Healthcare Japan CorporationSanken Bldg., 3-25-1, HyakuninchoShinjuku-ku, Tokyo 169-0073Japan29-0853-17 AA 11/2013

chain impacts represent 5% of the life cycle GWP impact and 11% of the life cycle CED impact. Environmental impacts from the end-of-life stage are higher for single-use but represent 1% of overall life cycle impacts. Fig 3. Cumulative Energy Demand (CED) and Global Warming Potential (GWP) results per life cycle stage 400 000 350 000 .

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