Environmental Performance of the

Medical-Biotechnology Sector

Semester Thesis WS 2003/04

Zurich, April 2004

Urs Rhyner

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Acknowledgments to: Project management: Gabriela Wülser, Seed Sustainability

Tutor: Rolf Frischknecht, ESU Services

Bank Sarasin: Andrew DeBoo, Eckhard Plinke

Berna Biotech AG: Martin Leuenberger.

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Executive Summary

Bank Sarasin is offering sustainability funds where investors have the guarantee that their money is invested in sustainable industry sectors. Sarasin is developing their own criteria for evaluating sustainability indicators of sectors. This semester thesis is a part of the evaluation of the medical-biotechnology sector.

The aim of the study was to find out relevant environmental impacts of Berna Bio-tech AG by analysing the production process of one specific product. It was planned to make an LCA of the production process of Aerugen where all inputs and outputs of the production have to be analysed. Aerugen is a conjugate vaccine produced by a biotechnological process, which uses bacteria to synthesise the vaccine.

The environmental impacts specific for the medical biotech sector are the extensive Quality Control, the continuous development of Living Species, the use of Animal Testing and the risk of GMO’s. There are approaches to implement a risk assess-ment of GMO’s or viruses in the LCA. Some more research needs to be done be-cause the impacts of the modified organisms are not yet well known. The possibility of implementing a risk assessment in the LCA makes it an even more valuable tool.

The collected data are analysed and interpreted as far as possible. Comparing the electricity, water and paper consumption per head of Berna Biotech AG with the ser-vice sector, it can be said that the consumed amounts of energy and paper are comparable and that the water consumption of Berna Biotech AG is bigger. The amount of produced solid waste is in the same range as well.

To analyse the environmental performance of Berna Biotech AG it is more efficient to make an energy and material flow analysis for the whole company than an LCA of a single product. By knowing the most important indicators like the energy, water and paper consumption, the CO2 emissions and the produced waste, and setting them in relation to the number of employees, it becomes possible to compare them with the results of other companies.

To get more information about the environmental performance of the medical bio-technology sector it would be useful to make a complete and detailed energy and material flow analysis of Berna Biotech AG and maybe of some other companies in this sector.

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1 Introduction and goal of the study ........................................5

2 Environmental impacts.........................................................6

2.1 Environmental standards and controlling ...................................... 7

2.2 Sector specific issues..................................................................... 7

2.2.1 Quality Control and its Consequences on Ecoefficiency...........................7 2.2.2 Living species ...................................................................................................7 2.2.3 Animal Testing..................................................................................................8 2.2.4 Genetically Modified Organisms (GMO) ......................................................8

3 Life Cycle Assessment.......................................................10

3.1 LCA Method..................................................................................10

3.2 LCA for Biotech-Companies.........................................................11

3.3 The aim of the assessment of Aerugen.......................................11

3.4 The Questionnaire ........................................................................12

4 Discussion of the collected data.........................................12

4.1 Rehhag facility ..............................................................................12

4.2 Pilot Plant (Building 79i) ...............................................................14

4.3 Relevant environmental impacts..................................................15

5 A solution for Berna Biotech AG ........................................15

5.1 Implementation.............................................................................17

6 Environmental Reports of other companies .......................18

6.1 Novozymes...................................................................................18

6.2 Roche............................................................................................20

6.3 Ciba Speciality Chemicals............................................................20

6.4 DSM ..............................................................................................21

6.5 Bank Sarasin.................................................................................21

6.6 UBS...............................................................................................22

6.7 Credit Suisse Group .....................................................................23

7 Conclusion.........................................................................25

8 Literature............................................................................26

9 Annex ................................................................................28

9.1 Additional information about Aerugen.........................................28

9.2 Credit Suisse VfU indices.............................................................30

9.3 Questionnaire................................................................................31

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Table of Charts Chart 1: Rehhag site, Berna Biotech AG...........................................................................12 Chart 2: Data from the Environmental Reports of the companies (Sarasin 2002;

Novozymes 2003; UBS 2003) .....................................................................................13 Chart 3: Pilot Plant Building, Berna Biotech AG...............................................................14 Chart 4: Chart 4: Berna Biotech AG, Business report 2003 ...........................................16 Chart 5: Novozymes, Accounts and data report 2003, p.39 ...........................................19 Chart 6: Roche Sustainability Report 2003 .......................................................................20 Chart 7: Ciba Speciality Chemistry, Eco-Efficiency Indicators, Water use 2003.........20 Chart 8: DSM, Triple P report 2003, p.28 ..........................................................................21 Chart 9: Sarasin, Umweltbericht 2002, p.5 ........................................................................22 Chart 10: UBS, Environmental Performance in figures 2003, p. 2 ................................22 Chart 11: UBS, Environmental Performance in figures 2003, p. 6 ................................23 Chart 12: CS, Sustainability Report 2003, p.16 ................................................................23 Chart 13: Credit Suisse Group, Energie und Stoffe Report 2002, p.15 ........................24

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1 Introduction and goal of the study

Bank Sarasin is offering sustainability funds where investors have the guarantee that their money is invested in sustainable industry sectors. Sarasin is developing their own criteria for evaluating sustainability indicators of sectors. This semester thesis is a part of the evaluation of the medical-biotechnology sector. The idea was to have a closer look at one specific biotechnology company to find relevant ecological indica-tors. The method of Life Cycle Assessment (LCA) was chosen to help finding signifi-cant impacts. The company which supported the idea and agreed to bring an effort was Berna Biotech AG, located in Bern Switzerland. Berna Biotech AG is a leader in the vaccines business. The project is an initiative of “Seed sustainability” which was also leading the project. The scientific support was provided from Dr. Rolf Frischknecht, ESU Services.

The aim of the study was to find out relevant environmental impacts of Berna Biotech AG by analysing the production process of one specific product. It was planned to make an LCA of the production process of Aerugen where all inputs and outputs of the production have to be analysed. Aerugen is a conjugate vaccine to prevent infec-tions with Pseudomonas Aeruginosa in patients who suffer from cystic fibrosis, a lung infection. Aerugen is produced by a biotechnological process which uses bacteria to synthesise the vaccine. (More Information about Aerugen can be found in the annex 9.1) It is a new vaccine and not yet on the market. The production of Aerugen is lo-cated in the pilot plant of Berna Biotech AG in Bern. Aerugen was chosen because the production process is typical for a vaccine produced by Berna Biotech AG. Fur-thermore the pilot plant is in a new building with more counters than in a less modern one hence it should be easier to measure certain inputs.

In this study an overview of environmental impacts specific for the medical biotech sector is given and an approach to conduct an LCA for Aerugen is outlined. The col-lected data are analysed and interpreted as far as possible. I propose as a more ap-plicable and straightforward solution to make an energy and material flow analysis instead of an LCA and I explain how this could be implemented by covering the most important indicators for the environmental performance of a company.

2 Environmental impacts

Ecology is one aspect which can be used to rate a company to determine whether it is more or less sustainable. Economical and social aspects are the others but not treated in this study. Obvious indicators to measure the ecological performance of any company are the use of energy, water and raw materials and the release of ex-haust gases, waste water and solid waste. These indicators can be put in relation to the number of employees, the output of products or the profit. There are other weight-ing possibilities as for example the damage oriented impact assessment. Depending on the specific industry there can be additional environmental impacts which can be relevant.

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2.1 Environmental standards and controlling

The national as well as the cantonal laws seem to be imprecisely defined. There are guidelines but it is up to the company to follow them and to inform the authorities which have to check the correctness of the company's declaration. In Switzerland there is a “Störfallverordnung” (Störfallverordnung 2000) which is a decree about avoiding accidents but the responsibility of applying those lies by the company. There are hardly any inspections concerning the fulfilling of environmental requirements. Depending on the appearance of a specific industry the cantonal authority which is responsible for the controlling is more or less big and well informed. It looks like there is need to catch up on regulations and controlling. In the case of an accident the re-sponsibilities may not clearly be distributed. Therefore it is important that the com-pany knows about its environmental impacts and the possible dangers involved. It can be observed that consumers expect companies to care about the environmental pollution and threats due to production processes. It can be very costly for a com-pany if they have to restore their image and the consumer confidence to their prod-ucts because of an environmental or safety scandal or accident.

2.2 Sector specific issues

Four relevant topics specific for the medical-biotech sector are examined and dis-cussed below.

2.2.1 Quality Control and its Consequences on Ecoefficiency

Quality Control is obviously one of the most important tasks of a pharmaceutical company like Berna Biotech AG. There are many “Good Manufacturing Practice” (GMP) requirements (ICH Steering Committee 2000) which have to be fulfilled and are strictly checked by the institution Swissmedic. The quality is therefore guaranteed by inspections. Mr. Leuenberger from Berna Biotech AG stated that the number of inspections increases every year. The whole controlling involves a huge amount of paper and energy consumption which is inevitable for the company. Every building has to be certified and each change has to be reported. For each modification with implications for the production process of a medicine the company needs a new na-tional and international approval which is combined with a significant amount of time and money, so there are very strong economic interests in not changing anything. Therefore the costs are much higher for changing for example the old air conditioning although the new could be run cheaper since it uses less energy. However, this cal-culation takes into account the economical costs for replacing the old air condition neglecting the ecological costs by keeping the old one. Electricity is cheap and ac-counts for a small fraction out of the production costs of a vaccine, so there is no special incentive to save electricity.

2.2.2 Living species

Berna Biotech AG is producing their vaccines with the help of bacteria. Species are developing constantly; therefore the production process needs to be adjusted con-tinually because the bacteria are changing as well as the pathogen which has to be eliminated. For this reason a biotechnological production process needs more re-search hence more resources than a chemical process which can be applied for thousands of times with no changes once it is set up. This problem is relevant if one likes to compare different production methods with each other.

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2.2.3 Animal Testing

A pharmaceutical sector specific issue would be the animal testing. Concerning a standard LCA the amounts of fodder and cadavers would be taken into account. Ethical concerns about animal testing could be an issue for sustainability indicators but are no subject of this semester thesis. It is furthermore no exclusion criterion for the bank Sarasin, which has elaborated its own standard concerning business that requires animal testing (DeBoo 2002).

2.2.4 Genetically Modified Organisms (GMO)

The production process of Aerugen does not include GMO's and therefore it is no subject of this study, but due to the importance and current interest of this subject it is of benefit to show how it could be possible to integrate the probable risk of GMO's in an LCA. It looks like biotechnological processes using bacteria and enzymes are cleaner in environmental terms than traditional processes (OECD 1998). Using GMO’s is possibly a relief to the environment in a short term but the implications are maybe more severe in a longer term perspective. An LCA could be the appropriate tool to measure the impacts in a holistic approach. A growing proportion of biotech-nology derived processes and products are based on the use of genetically modified micro organisms. This extends the analysis from the aspect of cleanliness to the as-pect of safety (Jank et al. 1999). (Risks in respect to human health may be due to pathogenicity, allergenicity or the production of toxic metabolites.)

It is usually easier to estimate the benefits of a technology than its risk. To calculate the risk with statistical data in the classical way, the risk is equal the damage size multiplied by the likelihood of an event. This formula does not work, if the damage is expected to be immense and the probability of the event is very small and hardly cal-culable.

The impacts of GMO’s are either unknown or debatable and not proven. But it would be useful to integrate threats to a sustainable development in an LCA; therefore new ways are needed to estimate risk. There are basically three ways of integrating risks of deliberate release of GMOs (Klöpffer et al. 2001).

1. Additional risk assessment

In addition to the quantitative impact assessment of an LCA a risk assessment of the possible risks is elaborated (Klöpffer et al. 1999). The two parts of a risk assessment are the risk analysis and the weighting of the risk. The risk analysis lists all the possi-ble risks known at the moment, conferring also to the existing rules from the EU commission: “Framework approach to environmental risk assessment for the release of genetically modified organisms” (EU Directive 2001). In the case of GMO’s risks involved can include pathogenicity to other organisms, potential of negative conse-quences to the human health, possible hybridisation with natural occurred organisms or genetic stability. The part of the risk weighting tries to estimate the probability of an event and discuss the consequences of different scenarios. Unfortunately it is not yet possible to make quantitative calculations like in the retro-perspective impact assessment of an LCA. There are not enough descriptive effects observed or they have maybe not been ob-servable so far but they will maybe appear in the future. This is the challenge of the prospective risk assessment. Often the effects are also very complex with many of parameters involved, not yet assessable and not transferable from a closed system to an open environment.

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2. Integration into existing categories of the impact assessment

It is possible to allocate potential effects due to GMO’s within the existing categories of the impact assessment (Klöpffer et al. 2001). The categories would be human tox-icity, ecotoxicity and land use. Starting with the potential risks (return to wildness, hybridisation, effect of cloning, horizontal gene-transfer), evaluating the effects (de-velopment of independent populations, change of existing populations, developing resistance to herbicides or antibiotics) and affected organisms (flora, fauna, human) and declaring the protective goods (human health, natural environment, man-built environment) leads to the three impact categories human toxicity, ecotoxicity and land use. The next step would be to determine the exposure factor per reference unit and the impact factor. It should principally be possible to determine an exposure factor per reference unit given by the inventory analysis. But to find out an impact factor, a li n-ear relation between the emission and the damage is necessary. This relation be-tween the quantity of the GMO and outcome of the impact is not feasible because of the possibility of an uncontrolled development of only a small fraction of GMO’s. Therefore it is not possible to quantify the impact of a GMO unit and thus the integra-tion of risks due to GMO’s into existing categories of the impact assessment is not satisfactory.

3. Development of a new impact category

In order to quantify the risk due to the release of GMO’s one can attempt to create a new impact category (Klöpffer et al. 2001). The category should fulfil the ISO stan-dards, has to allow comparisons between different GMO’s and makes quantitative impact assumptions. The output would be a risk number, derived from the impact assumption multiplied by the number of affected protective goods. For example if the risk category is hybridisation, the impact assumptions would be: observed in the envi-ronment = 3, proven in the laboratory = 2, possible but not proven = 1, improbable = 0. The affected safeguard subjects could be human health (intrinsic value of human life, economic value), natural environment (ecosystem, species, economic value of life supportive functions) or man-made environment (cultural, economic and intrinsic values). So, if hybridisation was observed in the environment and all three protective goods are affected, the risk number would be 3*3 = 9. The total risk number of a GMO would be the sum of all risk number of the different risk categories. For this method it is necessary to characterise every GMO sufficiently well so that most of the possible impacts are known. A factor to consider is the dependence of the GMO on the temperature and thus on the climate. The risk of releasing a GMO in the jungle is usually higher than releasing it in an ice desert.

The third method is the most feasible if quantitative results are required. But to obtain a result using the third method, the GMO has to be characterised very well, which is not the case for all species. However, this is the most scientific method and the one that should be developed further due to the possibility of integrating all known risks into an LCA. It is the responsibility of the scientific community, which is supporting the use of GMO’s, to further observe the impacts of GMO’s, so that the risk of unwanted environmental impacts can be avoided.

Taking GMO’s into account in an environmental impact study, the first method seems to be appropriate at this stage. It is a complete analysis where all the risks are listed and discussed but no risk numbers are given. With this additional risk assessment it would make it possible to see what specific risks the company is dealing with. This

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method would be accurate for a complete energy and materials flow study for Berna Biotech AG. It is important to mention the existence of GMO’s and biohazardous species like germs and viruses, explaining the related risks and possible outcomes as far as known up to now.

3 Life Cycle Assessment An LCA is a good tool to evaluate and quantify environmental impacts. There are several reasons why it is valuable for a company like Berna Biotech to use LCA (Braunschweig et al. 1993):

• A more detailed understanding of a process enables better controlling and optimisation of the process.

• Shareholders and stakeholders demand more and more proofs that com-panies care about the environment and the impact their products have.

• If an environmental accident would happen once, it is important that a company can show evidence that they actively tried to control their proc-esses and minimise risks.

• Efforts in environmental improvements can be a good marketing asset.

3.1 LCA Method

The standard approach of implementing an LCA is the following: goal and scope definition, inventory analysis, impact assessment and interpretation. For a preliminary assessment of the environmental impacts and for the evaluation of biotechnology-specific impacts, the Eco-Indicator 99, a damage oriented method for life cycle im-pact assessment has to be used (Goedkoop et al. 2001). This method considers three safeguard subjects:

Human Health: all human beings, in present and future, should be free from envi-ronmentally transmitted illnesses, disabilities or premature deaths. The category in-cludes the number and duration of diseases, and life years lost due to premature death from environmental causes. The included effects are: climate change, ozone layer depletion carcinogenic effects, respiratory effects and ionising (nuclear) radia-tion.

Ecosystem Quality: non-human species should not suffer from disruptive changes of their populations and geographical distribution. The category includes the effect on species diversity, especially for vascular plants and lower organisms. The included effects are: ecotoxicity, acidification, eutrophication and land-use.

Resources: the nature's supply of non-living goods, which are essential to the hu-man society, should be available also for future generations. The category includes the surplus energy needed in future to extract lower quality mineral and fossil re-sources. The depletion of agricultural and bulk resources as sand and gravel is con-sidered under land use.

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3.2 LCA for Biotech-Companies

From a scientific point of view an LCA should be as extensive as possible to cover all inputs and outputs. To compare different processes and products it is important that standardised LCA’s are used. However there are some companies using modified LCA’s to evaluate processes by comparing only certain impacts.

The Organisation for Economic Cooperation and Development (OECD) recommends in a paper “The Application of Biotechnology to Industrial Sustainability” (OECD 2001) the LCA as a good tool because the life cycle of a product from cradle to grave gives a global and holistic analysis. But they describe the standardised LCA as often too detailed and therefore too costly. They propose three different levels of LCA de-pending on the purpose and application. The simplest level of an LCA would be the “conceptual LCA” used to make an assessment of environmental aspects based on a limited and usually qualitative inventory. It is comparable with an energy and materi-als flow analysis of a product where only the most relevant indicators are chosen to be measured and analysed. Usually it does not cover the whole life cycle of a product but a part of it like a cradle to gate analysis. The “simplified” LCA covers the whole life cycle and provides essentially the same results as does a detailed LCA but with a significant reduction in expenses and time. That means that the guidelines proposed by the International Organisation for Standards (ISO, 1997, 1998, 2000a, 2000b) are not necessarily applied and that the evaluation and interpretation is not based on an impact assessment model but on a simple comparison of two production processes for example. The analysis focus more on financial impacts than environmental ones. The third level is the “detailed” LCA including a complete LCA as proposed by ISO. This standardised LCA is structured by goal and scope definition, inventory analysis, impact assessment and interpretation. The assessment can be complex but the re-sults are the most reliable and comparable. Software can ease the task of performing a full LCA.

The differentiation the OECD is proposing is not very stringent and it suggests that one can adopt the processes to suit a particular business. For an internal use it can make sense to simplify an LCA but comparing results with other companies is only possible with standardised LCA’s. The extend of a complete LCA is not comparable with an energy and materials flow analysis and it should therefore not been confused.

3.3 The aim of the assessment of Aerugen

The first step of an LCA is to define the goal and, very important, the system bounda-ries. The aim of this study is defined as following:

“Evaluation of the relevant environmental impacts of the vaccine Aerugen produced by Berna Biotech AG in Bern. Not only should the impacts of the production be taken into account but also the impacts of the whole “Rehhag” Facilities. Due to time and data constraints the work is restricted to an energy and material flow analysis. Raw and working materials needed for the production of Aerugen will not be analysed. Emissions specifically related to biotechnology, such as the release of germs via air and waste water, will not be considered.”

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3.4 The Questionnaire

The second step is to prepare a questionnaire for the structured collection of all the data needed for a complete inventory analysis (see annex 9.3). The goal of the de-rived balance sheet is to determine the relevant expenditures (energy, materials,...) and emissions (e.g. CO2, SOx, NOx,...) connected with the production of Aerugen. The questionnaire has to be relatively extensive to ensure a complete data set. It is likely that not all the requested information can be accumulated.

In the case of Aerugen, the questionnaire was divided in two parts; the first part asked about the production of Aerugen, the second about the secondary services such as management or quality control.

In the first part information about the pilot plant building was asked. The questions were about the reference unit, the land use of the plant, the use of electricity, water, gas and raw materials to measure the important inputs. One section was about the clean room, because it is a special issue for the medical industry. To quantify the outputs questions where included about solid waste, waste water and air emissions.

The second part of the questionnaire attempted to examine the secondary services with questions about the whole company in Bern, about the Research & Develop-ment department, the Quality Control, the management, the filling-packing and print-ing, the storage, the animal house, the energy supply and the waste water treatment. These were primarily questions about the energy, water and paper consumption, about the size of the buildings, the produced waste, the business flights or the air and water emissions.

4 Discussion of the collected data

The data collected through the questionnaire was supposed to be used for the inven-tory analysis and the impact assessment. Unfortunately it was not possible to collect all the data needed for a proper evaluation. Therefore only some relevant results can be discussed with the information given from the questionnaire. The reasons for the lack of data include the availability of the information and the time needed to organise them.

4.1 Rehhag facility

The analysed results for the Berna Biotech AG Rehhag site in Bern Bümpliz are:

Data of 2003 Total per employee unit Water consumption 41'000 128 m3 Electricity consumption 5'000 18 MWh Paper consumption 36'000 113 kg Solid waste 90'000 281 kg Number of employees = 320

Chart 1: Rehhag site, Berna Biotech AG

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These results reported only for one year do not tell a lot. A comparison over several years within the Berna Biotech AG would be more relevant. By comparing the results with other companies it is possible to interpret them better. The Banks Sarasin and UBS could be a proxy for the service sector. The Company Novoenzymes is produc-ing enzymes for different applications and is an example for another biotech com-pany. A comparison with the service sector is chosen due to the availability of the environmental indices of the service sector and due to the expected similarity of the two sectors. Both sectors are not raw material i ntensive as far as it can be estimated.

The water consumption per employee of Berna Biotech AG is clearly and not surpris-ingly bigger than the one of a bank. Berna Biotech AG uses the water for their pro-duction processes of the vaccines. The production processes of Novoenzymes seem to be more water intensive or the production volume per employee is bigger.

The electricity consumption per employee can only be compared with the Bank Sarasin because other companies often give information only about the total energy consumption including natural gas and oil. The comparison shows that the energy consumption per head of Berna Biotech AG about three times larger than the one of the Bank Sarasin.

The paper consumption per employee of Berna Biotech AG is in the same range as the paper consumption per employee of UBS and Sarasin. This outcome is in line with the expectation that pharmaceutical companies would have rather high paper consumption due to the administration of the Good Manufacturing Practise and the entire quality controlling process.

per employee unit Company Water consumption 128 m3 Berna (2003)

Electricity consumption 18 MWh Berna (2003)

Paper consumption 113 kg Berna (2003)

Waste 281 kg Berna (2003)

Water consumption 0.068 m3 Sarasin (2002)

Electricity consumption 5.3 MWh Sarasin (2002)

Paper consumption 194 kg Sarasin (2002)

Waste 228 kg Sarasin (2002)

Water consumption 1'084 m3 Novozymes (2003)

Electricity consumption not available MWh Novozymes (2003)

Paper consumption not available kg Novozymes (2003)

Waste 2632 kg Novozymes (2003)

Water consumption 27 m3 UBS (2003)

Electricity consumption not available MWh UBS (2003)

Paper consumption 219 kg UBS (2003)

Waste 413 kg UBS (2003) Chart 2: Data from the Environmental Reports of the companies (Sarasin 2002; Novozymes 2003; UBS 2003)

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The amount of solid waste produced per employee of Berna Biotech AG is compara-ble with the amount of solid waste per head produced by the banks. Novoenzymes produces much more solid waste per head. The factor between the amount of solid waste produced per employee by Berna Biotech AG and Novoenzymes is however the same as between the amounts of the water consumption per employee of these two companies.

To make general conclusions out of the comparisons between Berna Biotech and the two banks is not correct from a scientific and statistical point of view. There should be more results to make a complete comparison. Using only these results it can be said that the biotech sector is more water intensive and needs more electricity per em-ployee than the service sector. The paper consumption per employee is comparable within the two sectors. The amount of solid waste can differ significantly within the two sectors. These conclusions are very vague and have to be verified.

4.2 Pilot Plant (Building 79i)

The same analysis can be done for the pilot plant (building 79i) where Aerugen is produced. The results per employee of the pilot plant are similar to the results for the whole Rehhag facilities. The water consumption is probably smaller due to the small amount of Aerugen which is produced, while on the other hand Aerugen seems to be rather electricity intensive. The use of a clean room for the production of Aerugen could explain the high consumption of electricity. The amount of consumed paper and of solid waste per employee is smaller compared to amounts of the Rehhag fa-cilities. There are 55 employees working in the pilot plant building for the Research & Development and there are no administration facilities, which are usually more paper intensive.

Data of 2003 Total per employee unit Water consumption 5'000 91 m3 Electricity consumption 1'500 27 MWh Paper consumption 4'000 73 kg Waste 10'000 182 kg Number of employees = 55 Chart 3: Pilot Plant Building, Berna Biotech AG

It is a rough estimate that Aerugen is responsible for 15% of the whole company's expenses which is also reflected in the consumption of water and the amount of solid waste per employee.

Not answered in the questionnaire but discussed with Mr. Leuenberger from Berna Biotech AG are the raw materials needed for the production processes. He stated that only a negligible amount of raw materials are necessary for the production of Aerugen and that no hazardous materials are required. Some chemicals would be used as disinfectants and other pharmaceutical specific applications but only in small quantities so that there would be no reasons for concerns. However, disinfectants and solvents can have a considerable impact on the LCA of a product (González et al. 2003).

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4.3 Relevant environmental impacts

Are there any relevant environmental impacts due to the production process of Aerugen? With the data collected so far and the knowledge about the production process from Aerugen it can be said that there are no extraordinary impacts on the environment. This conclusion is only valid for Aerugen without knowing the raw mate-rials and chemicals used in the production process. The resource-consuming factors specific to this pharmaceutical production are the quality control and all the valida-tions involved, as well as the clean room equipment which uses additional energy and material. An aspect not included in this analysis is the risk of an accident where germs are released through the air or water to the close neighbourhood, which can put these people at risk. The probability is certainly small but still existing, though hard to estimate.

5 A solution for Berna Biotech AG

It had to be realised that it would be better to apply an environmental impact assess-ment to a whole location like Berna Biotech AG Bern-Bümpliz (Rehhag) Facility than to a specific product. For the Berna Biotech AG I would suggest a material and en-ergy flow assessment by location because a lot of information is easier to evaluate for the whole company than for one product. The most important indicators for the environmental performance of a product or company are:

• The energy consumption (electricity, oil, gas, coal)

• The emissions derived from the energy consumption (CO2, NOx…)

• The water consumption and eventually the emissions in the used water

• The raw materials consumption (paper, metals …)

• The solid waste production (mentioning recycling)

• The kilometres made by business travelling

This relevant information should be measurable without big expenditures. For a first analysis this approach would be a better applicable and straightforward solution, and by knowing those indicators it is possible to compare the environmental performance with other companies.

It would be important to organise a consistent and far reaching management of all data needed for an assessment of the whole company. Synergies should be used as the Good Manufacturing Practise (GMP) probably already covers much information which could be helpful. Once an appropriate data collecting management is set up, it is effortless collecting and evaluating all the information. One person could have the responsibility to collect all the data and to maintain a spreadsheet with the informa-tion from the whole company. It would maybe take a year until first meaningful con-clusions can be made but afterwards it will be a valuable tool and the results could be a part of the business report like in other companies such as Novozymes or Roche.

It would be interesting to analyse the different departments or even processes in terms of environmental impacts to see for what part each unit is responsible for. All

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the processes used by Berna Biotech AG to produce their vaccines are basically the same, so that it would be possible to adopt the management structure to all proc-esses. Knowing the impacts of several processes would allow comparisons which can be of interest for the company. It is possible to improve the controlling of the ma-terials and energy flows but it requires increased expenditures and a good data man-agement. Until now it is not possible to measure inputs of water and energy sepa-rately for each building or process but with little costs it would be possible to install counters. It is not necessary to know exactly all inputs for one specific process or product and it is not worth trying to do difficult measurements like measuring the steam volume used for a process. But with accurate data and the information from the whole data management it should be possible to get good and infotmative re-sults. Costs certainly set limits but a complete analysis is not only a tool to measure environmental impacts but also a tool to control the whole business performance of a process or product and it is therefore a functional management tool.

The different departments involved in the gate to gate analysis of Aerugen for exam-ple could be:

• Research & Development (including the animal house) • Quality Control • Filling-Packing-Printing • Storage • Management and Administration (including Marketing)

It is possible to roughly split the energy and material flows into the different units by knowing the share of a product on the cash flow of a company. This information can be found in the business report of a company. Another more precise but also more effortful approach sums up the working hours, which should be known for accounting reasons, of all departments related to each product.

Chart 4: Chart 4: Berna Biotech AG, Business report 2003

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5.1 Implementation

For an energy and materials flow analysis of a complete production site it is appropri-ate to account the data for a whole year, so that the inputs and emissions are listed per year (e.g. MWh/year). It is more difficult to calculate on the product base, where the reference unit would be a batch for example of Aerugen (kWh/batch). Aerugen and other vaccines are not produced continuously through the whole year because the needed amount can be produced in a shorter time. But to get information about, for example, the amount of oil used to produce 5000 units of Aerugen, equal to one batch, a separate installation of measuring equipment would be required if it is possi-ble at all.

A central heating system is used for the Rehhag Facilities and it is not possible to get specific data for one building. In addition the oil is not only used for the heat produc-tion but also for the steam production which is used as well for different production processes. Natural gas is used as well for the steam production what would make a splitting even more complicated. By analysing the whole company it is not necessary to split the used energy to the different applications. The sum of the consumed oil, gas and electricity is equal the total use of energy, which is partly responsible for the CO2 emissions of a company. The consumption of energy and CO2 emissions are important indicators of a company concerning its environmental performance.

The potable water used for the pilot plant could be measured because the pilot plant is a new building with a separate counter. The other buildings do not have a separate counter. Therefore it is easier to make an analysis for the whole Rehhag site than for one production process. The polluted water from all facilities flows together in one water treatment process. A reasonable approximation for the amount of polluted wa-ter is to the set the input of potable water equal to the output of waste water provided that a negligible amount of water is absorbed by the production. The polluted water containing germs is heated up to 124°C in an autoclave for 15 minutes at a pressure of 1 bar and then released as non biohazardous water. The waste water treatment is a standardised process recommended by the government. It would be important for a proper analysis to know the pollutants released to the public sewage system.

For an assessment it would be essential to report a solid waste management. Until now the solid waste was measured by the volume of the container, because the city of Bern is only changing now to account solid waste by weight. This makes it simple to report the amount of solid waste. No separation is made between organic and in-organic waste because the organic waste is treated in an autoclave at 124°C and then disposed with the inorganic waste. Biohazardous waste is treated in the same way and then disposed by incineration. If it is possible, it would be good to control also the recycling of materials like paper, cardboard, polymers, metals, glass and batteries if there are relevant amounts present. Measuring the kilograms of used pa-per is a good approximation for the paper consumption if it is too complicated to evaluate the amount of paper by orders.

It gives a good impression of a company if it reports also problematic issues like the risk of a release of viruses and if it gives a statement about its handling of animal test for example. Theoretically there should be no viruses released to the air due to the production processes and just in case there is a widely used filter for these kinds of applications where the producer gives the guarantee of zero penetrability for germs and viruses. There is no reason for Berna Biotech AG to be suspicious about the full guarantee, so there are no tests applied after the filter system for surveillance. How-

18

ever, it would make sense to list the possible risks and outcomes in an additional risk assessment, as described above, to see the specific risks the company is dealing with due to viruses, germs or GMO’s.

The evaluation of the kilometres made by the employees for business travel pur-poses is slightly more challenging but the amount of CO2 emissions can be relevant for international companies using air flights frequently. Train and car kilometres can be measured as far as possible and then used to formulate estimations.

The land use, derived from the building areas and parking lots would be needed for a complete LCA but it is not taken into account by an energy and material flow analy-sis. It could, however, be interesting to calculate the heat consumption per energy consuming area by knowing the heated areas of the facilities and the heat consump-tion as well. The facilities probably do not change significantly on a year to year ba-sis. So it has to be calculated only once and afterwards it has to be updated only in the case of significant changes.

The development of a product is negligible and is not taken into account from an en-ergy and material analysis related to a single product and not even in a cradle to grave LCA. The development time can hardly be optimised in terms of environmental impacts, and similar kinds of products need a comparable development time in order to compete in the market. The resources used for R&D are taken into account if an analysis is done for the whole company on a yearly base.

The total amount of the different indicators can be compared over the years within the company so that improvements can be seen or aimed at. Relating the indicators to the number of employees or to the amount of profit is useful to compare the results with other companies publishing the same indicators. I propose to relate the indica-tors to the number of employees because it is simple to elaborate and comparable with other companies.

6 Environmental Reports of other companies Just to give an idea how some companies publish their environmental impacts, seven interesting examples of different companies providing environmental reports are pro-vided. The way of presenting the impacts differs so that it is hardly possible to com-pare the companies with each other. Standardised methods would help to interpret the provided results. The companies are not chosen due to good or bad environ-mental reports or performances. Four companies are from the chemical and pharma-ceutical sector the other three are banks.

6.1 Novozymes

Novozymes is a Danish biotech company producing more than 100 enzymes for all kind of different applications. The enzymes are used for detergents, animal feed, nu-trition and textiles. The enzymes often replace traditional chemicals or additives and help to save water and energy in a variety of production processes. Novozymes also offers microbial fermentation and purification of biological compounds for the phar-maceutical and biotech industry. Novozymes is publishing a list of enzymes produced

19

with the help of GMO’s and explains its position to animal testing and its environ-mental and bioethics policy (Novozymes 2003). The business report contains some environmental indicators and the detailed data report contains the environmental data of the whole company. Information can for example be found about the number of accidents that happened with GMO releases, how many complaints they received or how many animals they used for testing. They also list the amount of biomass measured as the volume produced and transported from Novozymes as liquid fertil-iser or converted to a fertiliser product with a higher dry matter content. An additional report lists the environmental data for each production site.

To evaluate the environmental data they do not give the ratio per employee but cal-culate an eco-productivity index (EPI) for water and energy. The eco-productivity in-dex is calculated as a ratio of the total relative production output to the consumption of water and energy respectively, compared with last year’s figures.

EPI 2003 = 100)2002()2003(

)2002()2003(

××nconsumptionconsumptio

productionproduction

Chart 5: Novozymes, Accounts and data report 2003, p.39

20

6.2 Roche Roche provides a quite extensive Sustainability Report (Roche 2003) with a strong focus on safety issues due to the high amount of hazardous chemicals they are deal-ing with. They list all energy and material flows on an annual base and some of the indicators they set in relation to one million CHF sales.

Chart 6: Roche Sustainability Report 2003

6.3 Ciba Speciality Chemicals Ciba Speciality Chemicals publishes an EHS Report (Environment-Health-Safety) (Ciba Speciality Chemicals 2003) where Eco-efficiency indicators are given according to the reporting guidelines of the United Nations Conference on Trade and Develop-ment (UNCTAD 2003). These indicators are energy, water, global warming contribu-tion, ozone depleting substances and net value added. Net value added is the sales minus the costs of goods and services purchased minus depreciation. The indicators are related to tonnes per product and to the net value added.

Chart 7: Ciba Speciality Chemistry, Eco-Efficiency Indicators, Water use 2003

21

6.4 DSM

DSM is a Dutch company producing specialty chemicals; high quality biotechnologi-cal and chemical products for the life science industry and high quality materials. It provides a so called “Triple P” report (DSM 2003). P stands for People, Planet and Profit. In the section “Product and Service responsibility” of the Triple P report issues like biotechnology, animal testing and genetic modification are discussed. The planet-part of the Triple P report focuses on accomplished improvements and future reduc-tions of waste, energy and water consumption and emissions to the air and water. No indices or ratios are provided.

Chart 8: DSM, Triple P report 2003, p.28

6.5 Bank Sarasin

Bank Sarasin publishes an environment report (Sarasin 2002) where information is given about energy, water and paper consumption, the produced waste, a recycling quota, CO2 emissions and the kilometres accounted in business trips. VfU indices (Verein für Umweltmanagement) are related to the number of employees or the heat consumption to the energy-consuming area (EBF = Energiebezugsfläche). Environ-mental impact points (UBP = Umweltbelastungspunkte) are provided as well. The evaluated eco-efficiency is calculated as environmental impact per profit (UBP/CHF).

22

Chart 9: Sarasin, Umweltbericht 2002, p.5

6.6 UBS

UBS is publishing an environmental report (UBS 2003) providing information about environmental indices related per employee and lists the number of employees trained about environmental issues and the hours of training they received.

Chart 10: UBS, Environmental Performance in figures 2003, p. 2

23

Chart 11: UBS, Environmental Performance in figures 2003, p. 6

6.7 Credit Suisse Group

The Credit Suisse Group publishes different reports concerning environmental im-pacts (Credit Suisse Group 2003). The sustainability report does not contain quantita-tive environmental indices but an analysis of the strengths, weaknesses and the next steps.

Chart 12: CS, Sustainability Report 2003, p.16

VfU indices are given in the performance indicator report (see annex 9.2). An exter-nal company evaluates the energy and materials flow of the Credit Suisse Group in Switzerland focusing on the buildings. In that report indices are given related to the number of employees or the energy consuming area.

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Chart 13: Credit Suisse Group, Energie und Stoffe Report 2002, p.15

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7 Conclusion

It is not possible to draw conclusions from one single company about the environ-mental performance of the medical biotechnology sector. This study is also not suffi-cient to make final statements about the environmental impacts of Berna Biotech AG or Aerugen. Comparing the electricity, water and paper consumption per head of Berna Biotech AG with the service sector, it can be said that the consumed amounts of energy and paper are comparable and that the water consumption of Berna Bio-tech AG is bigger. The amount of produced solid waste is in the same range as well. The same is valid regarding these indicators for Aerugen. Referring only to these in-dicators, the Berna Biotech AG or the production process of Aerugen has no bigger impact on the environment than the service sector. To get a more complete picture it would be essential to include other important indicators like the total energy con-sumption, CO2 emissions and the risk coming from the existence of biohazardous species. The amount of raw material consumption needed for the production could not be analysed in this study but it seems to be a negligible indicator for this com-pany.

The aim of this work was to conduct an LCA for the production process of Aerugen but it had to be recognised that it is not possible to get all the necessary data. So far Berna Biotech AG does not have an environmental management which would allow the collection of the data needed for a complete LCA. Nevertheless the LCA is an appropriate tool for a holistic analysis of a production process due to the integrity and the standardised impact assessment. There are also approaches to implement a risk assessment of GMO’s or viruses in the LCA. Some more research needs to be done because the impacts of the modified organisms are not yet well known. The possibil-ity of implementing a risk assessment in the LCA makes it an even more valuable tool.

To analyse the environmental performance of Berna Biotech AG it is more efficient at the moment to make an energy and material flow analysis for the whole company than an LCA of a single product. In an analysis of the whole company every depart-ments like R&D, quality control and management would be included so that one gets a more or less complete overview. By knowing the most important indicators like the energy, water and paper consumption, the CO2 emissions and the produced waste, and setting them in relation to the number of employees, it becomes possible to compare them with the results of other companies. In a first step the data can be col-lected for the whole company and a splitting to the different departments or produc-tion processes can be done in a second phase by installing more measuring equip-ment or by applying information from the business report of the company. Managing this environmental data would be a valuable tool for Berna Biotech AG due to the better controlling of their needed resources and the possibility to publish them in the business report like some other companies do it.

To get more information about the environmental performance of the medical bio-technology sector it would be useful to make a complete and detailed energy and material flow analysis of Berna Biotech AG and maybe of some other companies in this sector. Applying the same indicators for every company makes them comparable with each other. The collection of the data needed for an energy and material flow analysis of the whole company should be easier than conducting an LCA of a pro-duction process.

26

8 Literature

Berna Biotech AG 2003: Bussines Report. www.bernabiotech.com

www.bernabiotech.com/investor/reports/index.html

Braunschweig, Arthur; Müller-Wenk, Ruedi 1993: Ökobilanzen für Unternehmungen: Eine Wegleitung für die Praxis; Paul Haupt Verlag Bern

Ciba Speciality Chemicals 2003: Environment-Health-Safety Report www.cibasc.com www.cibasc.com/VIEW.ASP?ID=2242

Credit Suisse Group 2003: Sustainability Reporting www.creditsuisse.com www.creditsuisse.com/en/annualreporting2003/sustainability_reporting_2003

DeBoo, Andrew 2002: Animal Testing as an Exclusion Criterion; Sarasin Sustainable Investment

DSM 2003: Triple P report www.dsm.com www.dsm.com/en_US/media/press_releases/08_04_Triple_P_Report_2003

EU Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001: on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC. Official Journal of the European Communities, 17.4.2001 L, 106/1 EN.

Goedkoop, Mark; Spriensma, Renilde 2000: The Eco-indicator 99, A damage ori- ented method for Life Cycle Impact Assessment: Methodology Report, Third edition 22 June 2001 and Manual for designers, Second edition 17 April 2000. PRé, Product ecology consultants. www.pre.nl

González, Jiménez; Curzons, Alan D.; Constable, David J.C.; Cunningham, Virginia L. 2003: Cradle-to-Gate Life Cycle Inventory and Assessment of Pharmaceutical Compounds. The international Journal of Life Cycle Assessment, LCA Case Studies (Online First); Corresponding author: conchita.j.gonzales@gsk.com

ICH Steering Committee 2000: International conference on harmonisation of techni- cal requirements for registration of pharmaceuticals for human use; Draft Con- sensus Guideline: Good Manufacturing Practice Guide for Active Pharmaceuti- al Ingredients.

International Organization for Standardization (ISO) 1997: Environmental Manage ment - Life Cycle Assessment - Principles and framework. European standard EN ISO 14040 Geneva.

International Organization for Standardization (ISO) 1998: Environmental Manage ment - Life Cycle Assessment - Goal and scope definition and inventory analy sis. European standard EN ISO 14041 Geneva.

International Organization for Standardization (ISO) 2000a: Environmental Manage ment - Life Cycle Assessment - Life Cycle Impact Assessment. European standard EN ISO 14042 Geneva.

27

International Organization for Standardization (ISO) 2000b: Environmental Manage ment - Life Cycle Assessment - Life cycle interpretation. European standard EN ISO 14043 Geneva.

Jank, Bernhard; Berthold, Aline; Alber, Sebastian; Doblhoff-Dier, Otto 1999: Assess- ing the Impacts of Genetically Modified Microorganisms; The international Jour- nal of Life Cycle Assessment (vol.4, No.5,1999); Corresponding author: Dr. Bernhard Jank, Institute of Applied Microbiology, University of Agriculture, Nußdorfer Lände 11, A-1190 Vienna, Austria

Klöpffer, Walter; Renner, Isa; Tappeser, Beatrix; Eckelkamp, Claudia; Dietrich, Ri-chard 1999: Life cycle assessment gentechnisch veränderter Produkte als Ba sis für eine umfassende Beurteilung möglicher Umweltauswirkungen; Umwelt-bundesamt GmbH, Wien

Klöpffer, Walter; Renner, Isa; Schmidt, Elisabeth; Tappeser, Beatrix; Gensch, Carl-Otto; Gaugitsch, Helmut 2001: Methodische Weiterentwicklung der Wirkungs abschätzung in Ökobilanzen (LCA) gentechnisch veränderter Pflanzen. Mono-graphien Band 143, Umweltbundesamt GmbH, Wien

Novozymes 2003: Business Report www.novozymes.com

www.novozymes.com/cgi-bin/bvisapi.dll/ar2003/report.jsp?lang=en

OECD 1998: Biotechnology for Clean Industrial Products and Processes

OECD 2001: The Application of Biotechnology to Industrial Sustainability

Roche 2002: Sustainability Report www.roche.com www.roche.com/home/sustain/sus_cen/sus_cen_rep.htm

Störfallverordung 2000, StFV 814.012 vom 27. Februar 1991Verordnung über den Schutz vor Störfällen; (Stand am 28. März 2000)

Sarasin 2002: Umweltbericht www.sarasin.ch

www.sarasin.com/sarasin/show/main/public/1,1015,1000306-0-2,00.html

UBS 2003: Environmental Report www.ubs.com www.ubs.com/e/about/ubs_environment/environment/reports/2003.html

UNCTAD 2003: Reporting Guidelines: www.unctad.org/en/docs//iteipc20037_en.pdf

VfU Verein für Umweltmanagement in Banken und Versicherungen: www.vfu.de

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9 Annex

9.1 Additional information about Aerugen

(From the Berna Biotech AG Business Report 2003)

Since November 2003, Aerugen® has been produced in the new facility at Berna headquarters. Aerugen® is the first vaccine for the active prophylaxis of Pseudomo-nas aeruginosa infections in cystic fibrosis patients. The vaccine aims to prevent this progressive deterioration of the lungs which severely impairs the quality of life and life-expectancy of cystic fibrosis patients.

Cystic fibrosis is an incurable hereditary disease that is characterised by the produc-tion of a very viscous mucus in the lungs, pancreas, and the small intestine. Conse-quently, the function of these organs is affected and the colonisation of the lungs by bacteria, especially Pseudomonas aeruginosa, is accelerated. Colonisation with bac-teria often causes chronic infections and the resulting progressive deterioration of the lungs severely impairs the quality of life and life-expectancy of the patients.

Aerugen® is the first vaccine for the active prophylaxis of Pseudomonas aeruginosa infections in cystic fibrosis patients. Cystic fibrosis – a genetically induced malfunc-tion of the mucus-producing glands – is a relatively rare disease affecting 40 000 pa-tients in Europe, but it is the most common hereditary metabolic disease. Various serotypes of Pseudomonas aeruginosa are found in cystic fibrosis patients. The indi-vidual serotypes carry different lipopolysaccharides on their surface. The immune system is able to recognise the polysaccharide component and induce an immune response. Therefore, a Pseudomonas aeruginosa vaccine must contain the relevant serotypes. Aerugen® is an octavalent conjugate vaccine, combining the polysaccha-rides from eight prevalent serotypes. However, the polysaccharides alone are not sufficiently immunogenic. They require an additional element in order to stimulate the immune system and to induce sufficient immunogenicity. Aerugen® combines the polysaccharides with the protein Exotoxin A, which is also produced by Pseudomo-nas aeruginosa. The combination of nine different components in Aerugen®, make its production very complex and demanding. The production plant for Aerugen® that was built in 2001/02 was approved by the Swiss authorities in September 2003. Pro-duction according to “Good Manufacturing Practice” started in November 2003.

Interview with André Collioud, Head of Process Development Switzerland, on the production of Aerugen® in the new plant.

How can you describe the production process? André Collioud: Nine different Pseudomonas aeruginosa strains constitute the begin-ning of the production chain. Eight strains are needed for the extraction of the corre-sponding polysaccharides. The ninth strain is used for the production of the exotoxin. The fermentation of the bacteria, as well as the purification of the polysaccharides, is a successive process. The purified polysaccharides represent the first eight interim products. Another interim product is the purified exotoxin A, which is combined in a further step with the corresponding polysaccharides. This process is implemented separately for every polysaccharide, resulting in eight different single conjugates.

29

So this constitutes another set of intermediate products? Correct. The formulation of the vaccine takes place in the final production phase, where eight different conjugates are combined into one product.

How long does the entire production process take? Approximately four months.

The production of such a complex product probably requires a very experienced, well-established team? Indeed, the team must be able to manage all aspects of process development as well as technical and regulatory issues. Working with live cells is not a trivial task. The smallest changes may have a significant impact on the product. Therefore, the au-thorities require the production of three consecutive lots. This involves the production of the vaccine three times in a row with no discrepancies in the specifications in order to demonstrate the reproducibility of the process and the quality of the product.

How big is your team? I have sixteen experienced team members who are involved in the production of Aerugen®. They devote approximately 30 percent of their working time to fulfilling the quality guidelines.

Aerugen® is being produced in a new plant. What were your requirements with re-gard to the design? Designing a new plant always provides a unique opportunity to utilise the most recent technology. It was important to realise a concept which meets our present needs but will also allow a great deal of flexibility in the future.

What is the actual size of the plant and what does it contain? The building has four floors with a volume of 20 000 cubic meters. It contains a de-velopment facility allowing us to manufacture clinical trial material as well as com-mercial vaccines under the current guidelines of “Good Manufacturing Practice”. The process development and research departments each occupy a separate floor within the building. And as already mentioned, if necessary, we are able to install, upgrade or rebuild existing or new technical facilities within the building.

How much time passed from start to finish? Two years. In February 2001 we started building the multi-purpose facilities and in June 2002 the interior was completed. We then had to implement measures to meet the regulatory requirements allowing us to start production in November 2003. The total project costs amounted to more than CHF 20 million.

Did everything go according to plan? There are always unforeseen events but despite the numerous technical and regula-tory details which had to be taken into account, and some inevitable surprises, we were able to stay within our set timeframe. Finally, the Swissmedic inspection of the facilities went very smoothly, confirming once again the quality of our project execu-tion. André Collioud

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9.2 Credit Suisse VfU indices

Credit Suisse Group Sustainability Report 2003, indicators and key figures

31

9.3 Questionnaire

1 Introduction........................................................................32

2 Production of Aerugen .......................................................32

2.1 Information about the Building 79i...............................................32

2.2 Reference unit...............................................................................33

2.3 Energy use....................................................................................33

2.4 Water use......................................................................................33

2.5 Gases............................................................................................33

2.6 Materials and Products.................................................................34

2.7 Clean room equipment.................................................................34

2.8 Solid Waste...................................................................................34

2.9 Waste water..................................................................................35

2.10 Air emissions.................................................................................35

3 Secondary Services...........................................................35

3.1 Reference unit...............................................................................35

3.2 General information about Berna Biotech AG.............................36

3.3 Research and Development ........................................................36

3.4 Quality Control ..............................................................................37

3.5 Management.................................................................................37

3.6 Filling-Packing-Printing.................................................................37

3.7 Storage..........................................................................................38

3.8 Animal House................................................................................38

3.9 Energy supply...............................................................................38

3.10 Central used water treatment (if any) ..........................................39

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1 Introduction

The relevant environmental impacts of the vaccine Aerugen are going to be evalu-ated. The pilot production plant is located in Bern-Bümpliz (Rehhag-Facility 79i). Not only the impacts of the production are taken into account but also the impacts of the development, the quality control and management related to the product. The trans-portation of the raw materials to Bern-Bümpliz is not taken into account. Due to time constraints the work is restricted to a gate-to-gate analysis. The production of raw and working materials needed for the production of Aerugen will not be analysed. Emissions such as the release of germs via air and wastewater will be considered.

The goal of a balance sheet is to determine the relevant expenditures (energy, mate-rials,...) and emissions (e.g. CO2, SOx, NOx,...) connected with the production of Aerugen, which are used for the LCA. Since the questionnaire is relatively extensive, it is maybe not possible to find the information for every question, or data for some of the secondary services are only available on an aggregated level (e.g., research, quality control and management together). Please indicate such regrouping of the services.

If you have more relevant information about the energy- and material flow than asked in this questionnaire, please add it at the end of the respective table.

If you have any questions by answering the questionnaire, please don't hesitate and contact me:

Urs Rhyner: urrhyner@student.ethz.ch, 079 415 07 32

2 Production of Aerugen Questions about resources, energy use and emissions of the production of Aerugen, concerning the direct energy use and the direct emissions of the production.

2.1 Information about the Building 79i

Questions about the building 79i where the pilot plant for the production of Aerugen is located. Building 79i Notes Size of the building area m2 1300 Volume of the building m3 20500 Function and volume of each floor 1 Technik, Lager, Büro 4450 2 Produktion 6050 3 Technik 5100 4 Labor, Technik, Büro (Forschung) 5000

33

2.2 Reference unit

For which reference unit is the following information valid?

1.) one year, only for the production of Aerugen 2.) one year, for the whole building 3.) for a certain quantity of Aerugen

If 1. or 2: which quantity of Aerugen is produced in one year?

5000 units (1 unit = 1 portion of vaccine)

If 3.: for which quantity of Aerugen?

For which year is the information valid?

2.3 Energy use

The "total use of electricity" is the sum of all electricity used for the production of Aerugen.

Energy use Amount per ref-erence unit

Notes

Total use of electricity Building 1‘500‘000kWh

Total use of electricity 1'050‘000kWh ca. 70%

Electricity used for the produc-tion machines

kWh Not measured separately

Electricity used for the clean room system (air condition)

kWh Not measured separately

Electricity used for the auto-clave

kWh Not measured separately

Electricity used for the water preparation

kWh Not measured separately

Heat consumption (steam and heating together)

MJ Not measured separately

2.4 Water use

The "total use of potable water" is the sum of all kind of waters used.

Water use Amount per ref-erence unit

Notes

Total use of potable water 5000 m3 Water used untreated l Use of deionised water l Use of special clean water l

Will be reported in January

Additives used for the water treatment (what kind and amount)

Regenerating salt, amount will be reported in January

2.5 Gases

Gases Amount per ref-erence unit

Notes

Oxygen m3

Nitrogen m3 Will be reported in January

others m3

34

2.6 Materials and Products

Information about products bought from a supplier.

Products Amount per ref-erence unit

Notes

Bacteria's

Nutrition for bacteria's (saccha-rin's: kind, amount)

kg

-

other additives (kind, amount)

-

The production materials list is not available before January

Packaging materials for Aerugen (kind, amount)

-

2.7 Clean room equipment

Products required for the use of the clean room.

Products Amount per ref-erence unit

Notes

Sterile clothes kg

Masks kg

Gloves kg

Disinfectant (kg or litre)

Others (kind and amount):

-

Products Pieces Socks 181 T-Shirt 171 Saturn-overall 9 Clean room shoes 25 Mars-coat 113 Vega-trousers 36 Vega-jacket 36 Clog Luxe 26 OP Clog 29 Clog Labor 4 Safety googles 4 Cadmo-shoe 8

2.8 Solid Waste

How much solid waste is produced per reference unit?

Solid waste Amount per ref-erence unit

Notes

Organic waste

Inorganic waste ca. 80‘000 litres solid waste for incineration**

Bio hazardous waste kg none

Others (kind and amount):

- kg **The amount of solid waste of the pilot plant includes the waste of the wrapping of the new equip-ment. By asking cities which already apply the waste accounting by weight, it seems reasonable to set one container of 800l equal to 100kg of waste.

35

2.9 Waste water

Waste water directly linked to the production process of Aerugen, if the information is available.

Waste water To the basin (water pre-treatment)

To the public canali-sation

Amount m3 Germs, viruses, bacteria's (kind and amount)

- mg/l other pollutants (kind and amount) - mg/l - mg/l

2.10 Air emissions

Air emissions directly linked to the production process of Aerugen. (That doesn't in-clude emissions from energy supply, see Section Fehler! Verweisquelle konnte nicht gefunden werden.)

Air emissions Amount per reference unit

Notes / Production step

Germs, viruses, bacte-ria's (kind and amount):

- kg - kg other pollutants (kind and amount):

- kg - kg

None, exhausted air is filtered by an absolute filtration so called „HEPA“. Exact type will be reported in January.

3 Secondary Services

Energy and mass flows of research and development, quality control, management and other services related to the production of Aerugen.

3.1 Reference unit

For which reference unit is the following information valid?

1.) one year, only for the production of Aerugen 2.) one year, unspecified use 3.) other

If 2: Share (%)of Aerugen on the whole production of Berna Biotech?

15% (must be checked in January)

If 3.: explanation

For which year is the information valid?

36

3.2 General information about Berna Biotech AG

Information, which is maybe relevant for the life cycle assessment, including all "Rehhag" facilities .

Company Notes

Size of the company area (Rehhag)

m2 Maybe more precise informa-tion about green areas, build-ing areas, parking lot ...

Total area m2 29‘700 Building areas m2 11‘600 Surrounding area m2 18‘000 - Hard cover m2 9‘000 ca. 50% - Green area m2 6‘500 ca. 30% - Rest m2 2‘500 ca. 20%

Kind of area Industrie and busi-ness

e.g. Industry area, business area, city area, countryside

Amount per refer-ence unit

Total heat consumption MJ Not measured Total use of potable water m3 36’000 Total use of tap water % ? Total use of ground water % ? Total use of surface water % ? Total use of recycled water % ? Total of solid waste 300 Containers 800l each** t 60 Big containers

Total use of paper Ca. 40% of solid waste

Total use of electricity kWh 5'700’000 Total use of gas kWh 4'700’000 Total use of oil l will be reported in January **By asking cities which already apply the waste accounting by weight, it seems reasonable to set one container of 800l equal to 100kg of waste.

3.3 Research and Development R&D Notes

Size of the building area m2

Amount per ref-erence unit

Heat consumption MJ

Use of potable water m3

Solid waste kg Electricity kWh

Paper consumption kg

Share of Aerugen on the R&D? %

37

3.4 Quality Control Quality control Notes

Size of the building area m2

Amount per ref-erence unit

Heat consumption MJ Use of potable water m3 Solid waste kg Electricity kWh Paper consumption kg Share of Aerugen on the quality control?

%

3.5 Management Management Notes

Total size of the building areas m2

Amount per ref-erence unit

Heat consumption MJ Use of potable water m3 Solid waste kg Electricity kWh Paper consumption kg Business flights km Share of Aerugen on the man-agement?

%

3.6 Filling-Packing-Printing F-P-P Notes

Size of the building area m2

Amount per ref-erence unit

Heat consumption MJ

Use of potable water m3

Solid waste kg Electricity kWh

Paper consumption kg

Share of Aerugen on F-P-P? %

38

3.7 Storage

Relevant if Aerugen is stored centrally.

Storage Notes

Size of the building area m2

Amount per ref-erence unit

Heat consumption MJ

Use of potable water m3

Solid waste kg Electricity kWh

Share of Aerugen on storage? %

3.8 Animal House

Relevant if animal testing was necessary for the development of Aerugen.

Animal House Notes

Size of the building area m2

Amount per ref-erence unit

Heat consumption MJ

Use of potable water m3 Solid waste kg

Cadavers kg

Electricity kWh Fodder (kind; amount) kg

Share of Aerugen on the animal house?

%

3.9 Energy supply

Energy supply Notes

Size of the building area m2

What kind of energy supply systems are used?

What kind of exhaust gas purifi-cation is used?

Amount per ref-erence unit

Fossil fuel consumption (what kind of fuel)

l Amount will be reported later

Natural gas consumption 4’700’000 KWh

Consumption of other energy sources, self production (kind and amount)

Share for steam production % Use of potable water m3 Electricity (for circulating pumps, etc,)

kWh

Share of Aerugen on the energy supply?

%

39

Energy supply Notes

Electricity used for the air com-pressor in building 79F

kWh

Air emissions Amount per ref-erence unit

Notes / Production step

CO2 kg CH4 kg Carbon monoxide kg NMVOC kg NOx kg PAK kg SOx kg PM2.5 kg PM10 kg Dust in total kg

3.10 Central used water treatment (if any) Used water treatment Notes

Size of the building area m2

Amount per refer-ence unit

Use of potable water m3 Electricity kWh

Share of Aerugen on the used water treatment?

%

Waste water To the basin (pre-treatment)

To the public se w-age

Introduced amount m3 Germs, viruses, bacteria's (kind and amount):

- mg/l - mg/l - mg/l other pollutants (kind and amount): - mg/l - mg/l - mg/l