selim

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Presentation Summary

• Introduction Background and Projects
• Emerging materials assessment methodologies.
• Life Cycle Assessment methods, softwares,
  examples
• Process Based Cost Modelling method, examples
• Need for innovative methods Envt. Value Market
  potential
• New Materials the Biopolymer challenge
• Definition, production/market data
• Main Suppliers

• Properties, tech. Data, samples
• Market developments, trends, takes
• Biopolymers biodegradable, compostable or
  sustainable
• Possible applications injection devices
• Assessment Tools applications, enhancing products
  sustainability cartridges and injecting devices.
  Primary secondary packaging materials rubbers,
  silicones, glasses, polystyrols, PVC, PP..
• Green Marketing, regulations
• Biopolymer substitution
• Conclusions and suggestions

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• Introduction background and projects
• Materials assessment methods and tools the
  process engineer touch
• Biopolymer challenge
• Possible applications
• Injections devices
• Biopolymer substitution
• Suggestions

OUTLINE
Novo Nordisk, Hilleröd September 7th, 2004
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Selim Nouri MSc Injénieur process, Institut
National Polytechnique de Lorraine, Nancy,
France.?

• Education, background
• Born near Versailles.
• Imperial Park junior and senior high school in
  Nice
• schools specialising in preparing pupils to take
  Grandes Écoles entrance, Lycée Massena, Nice
• Grande Ecole, ENSIC, Nancy

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Selim Nouri MSc Injénieur process, Institut
National Polytechnique de Lorraine, Nancy,
France.(? me)

• Recent History and Projects
• Jan 04 - Now AGS Project Engineer
• 2003 AirLiquide graduate trainee
• 2002 French Agronomy Institute
• 2000 Atofina hands-on internship
• Previous Chalmers Exchange student in
  sustainable development (Environmentally
  Sustainable Process Technology Master Programme)

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• Heat shock enhanced hgH production project
• Heating devices and thermocontrol techniques
• Clean room environement
• Biologists, geneticians

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• Process integration, Aspentech soft,
  International RD work Environment
• Sustainable process, emissions reduction, waste
  management

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• AGS international partnership MIT-ETHZ-CTH-UT
• Application and refinement of the sustainability
  assesment methodology sustainable polymers.
• Work Environment ESA (LCA, Envt, technical
  change) MIT (PBCM, , early developement)
• Industries

Etc..
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Emerging material assessment Methodologies LCA

• Life Cycle Assesment definition
• Cradle to Grave snapshot which can be used to
  evaluate economic, social and environmental
  issues associated with a product/process.
• A holistic approach to identify opportunities to
  reduce cost and environmental impact.

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LCA procedure


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LCA CTH competence

• Environmetal System Analysis Department
  specialised in LCA för 10 år
• The research focus on two perspectives, how the
  environmental tools (i.e. LCA, EMS, etc.) are
  used
• "Tools seen from within", i.e. tools development
  and use (case studies).
• "Tools seen from the outside", i.e how the
  environmental tools and methods are used in
  decision making
• CiT Ekologik (a Chalmers Industriteknik company)
  Developps and sell LCA software

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LCA softwares

• consumer oriented software light-version
• Professional software online databased,
  integrated Software, LCA button

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LCA results example

• GWP
• NRR use
• Conclusions?
• Cf. The new danish
• packaging tax

Patel 2001
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Two types of LCA

• State-oriented (accounting)
• Change oriented (effects of change)

2004
Sanden 2004
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Two types of LCA

• State-oriented (accounting)
• Change oriented (effects of change)

2004
Sanden 2004
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Two types of LCA

• State-oriented (accounting)
• Change oriented (effects of change)

2004
Sanden 2004
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Process-Based Cost Modeling (PBCM) the
engineering approach to techno-economics
questions (R. Kirchain MIT)

• Objective
• - Map from Process Description To Operation
  Cost
• Purpose
• - Inform Decisions Concerning Technology
  Alternatives BEFORE Operations are in place

Kirchain 2004
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PBCM Forecasts Manufacturing Requirements and
Costs

• PBCM builds cost up from technical detail,
  forecasting
• - Processing requirements
• Cycle times, equipment specifications
• - Resource requirements
• Number of tools, equipment, and laborers

Kirchain 2004
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PBCM Provides Key Insights to StrategicPerformanc
e

• Strategic strengths and weaknesses
• Production volumes
• Factor conditions
• Key cost drivers
• Allows detailed scenario analysis
• Widely applied to explore component production

Kirchain 2004
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PBCM for Early Stage Technologies

• Process-based Cost Models can be applied to
  explore very early stage technologies
• Based on known technical details
• Early stage estimates are more uncertain
• Identifies cost drivers
• Quantifies needed technical hurdles
• Allows technology-driven sensitivity analyses
• Confirms strategic strengths
• Case example
• Emerging processes for Titanium production
  Three competing technologies

Kirchain 2004
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PBCM Main advantages

• Process based cost model affords robust method
• Identifies cost drivers
• Quantifies needed technical hurdles
• Allows technology Allows technology-driven
  sensitivity analyses
• Confirms strategic strengths
• PBCM can be applied to early stage technologies
• Can forecast the impact of technical change

Kirchain 2004
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Need for Innovative Integrated Methods

• Adress the issues that drive a materials
  potential for commercialization including those
  that determine its resource and envt. Impact.
• Require an internally consistent synthesis of all
  current analytical methods

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• Require examining materials substitution from 5
  perspectives
• Cost, tech. and Envt. Performance to lead to
  adoption
• Potential for material/process to achieve those
  characteristics
• The net impact on environment from an emerging
  technology over the entire material cycle
• The manner new material markets are expected to
  evolve on demand
• The mechanisms for communicating those info to
  decision makers and product designers

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Current research status at ESA

• Tools to Answer questions like How to assess the
  environmental impact of investments in new
  technologies?
• We work along two lines
• Adapt and extend LCA methodology PBCM
• Develop new methodology
• Technology path assessment (Sanden, Jonasson)

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Ultimate Goal

• Development of an integrated assessment
  methodology/software that enable positioning its
  user to be a world leader in identifying
  sustainable materials alternatives.
• ? new materials

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New Materials The biopolymers challengeDefinitio
n

• Polymers from renewable natural resources, are
  called biopolymers
• Often biodegradable and not toxic to produce
• Can be produced by biological systems
  or chemically synthesized
• Alternative to petroleum-based polymers
• Starch-based polymers are often blends of starch
  and PE

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Production and Market data

• Production 200 million pounds (prediction) vs
  200 billion lbs plastics in the US alone
• Consumption biodegradable polymers US 50 W.
  Europe (40) and Japan (10)

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Main Producers

• Polylactic acid (PLA)
• Cargill Dow (NatureWorks)
• Mitsui (Lacea)
• Cellulose (acetates)
• Eastman (Tenite)
• IFA (Fasal)
• Mazzucchelli (Bioceta)
• UCB (Natureflex)
• Starch blends
• Biotec (Bioplast)
• Novamont (MaterBi types)
• Lactide/glycolide polymer
• PURAC (Purasorb)
• Boehinger-Ingelheim (Resomer)

• Polyesters
• BASF (Ecoflex)
• DuPont (Biomax)
• Eastman (Eastar Bio)
• Showa Denko (Bionolle)
• Solvay (Capa)
• Plant base starch
• Novamont (MaterBi)
• Rodenburg Biopolymers (Solanyl)
• Pollyhydroxyalkanoates
• Biomer (Biomer)
• PHB Industries (Biocycle)
• ICI (Biopol)

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Market developments

• What attracts biopolymers to the market?
• decrease (landfill) waste
• save fossil fuels/energy
• become more independent of fossil fuels
• reduction of GHG-emissions
• specific material properties

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Biopolymer market size and longevity

• World market could grow 30 per year for next
  decade
• Biopolymer plastics could eventually capture
  10-20 of overall plastic market
• Major drivers
• Oil/crop price ratio
• Disposal issues
• Technology advances
• Climate change concerns

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Market developments, financial data

• Packaging Market (high volume, low price)
• High value applications drug delivery, medical
  care (low volume, high price)
• Global drug delivery market expected to be 70
  Billion by 2005
• Injectable market worth 16 Billion today
• - Expected to double by 2005
• Biotechnology drugs are losing patent protection
• New biotechnology products will require drug
  delivery solutions to reach their potential

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Strong pipeline to support sales growth
(NovoZymes Financial results 1H 2004)- more than
100 projects - approx. 13 of sales spent on RD
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Biopolymers biodegradable, compostable or
sustainable?

• Biopolymers should fit the waste management
  system look at the whole picture.
• Germany packaging waste recycled 75 (2001)
• Ireland packaging waste recycled 28 (2001)
• Singapore 10 plastic recycled (2001)
• USA less than 10 plastic recycled (2001)

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Possible application injection devices

• Green marketing
• is made of environmentally friendly materials
  (polypropylene) which, after incineration, breaks
  down into water and carbon dioxide.
• Helping in the material choice for products
• Primary Packaging material - silicons, glass
• Packaging cartridges inserted into trays made of
  polystyrol or PVC
• Help in the early development phase and material
  substitution.

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Possible application injection devices. Why?

• Need of injection devices
•  Simplify drug administration
•  Increase dosing accuracy
•  Reduce admix labor
•  Minimize needle phobia (cf. Antares growth)
•  Comply needle safety law
• Reduce injection pain
•  Differentiate a product
• Enhance product value ?
• AAPS Drug Delivery Device Workshop Judy Y. Chang

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Possible application injection devices. Why?
Injection Devices

•  Auto-injectors
•  Pen systems Novo, Lilly, Sanofi-Aventis
• Mini pumps/patch systems
•  Needle free injectors Antares
•  Other injectors
•  Needle safety devices
• AAPS Drug Delivery Device Workshop Judy Y. Chang

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Possible application injection devices. Why?
Industry Trend

•  Pre-fill drugs in syringes or cartridges
•  Incorporate injection devices
•  Moving toward disposable devices
• (cf. The Novo Nordisk insulin volume
• split by injection method)

?? Enhance convenience and compliances ? ??
Increase competitive edge ?
Chang 2004
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Pathways to product competition
patterns of product competition as markets mature
In this stage products that are disruptively
simple and convenient ? become most successful
Functionality
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Possible application injection devices. Why?
Multiple Discipline Interrelationship
Commercial need
? Primary container
Target product profile

• Product differentiation ?
• Competition
• User profile
• Desire alternate configurations?

• Syringe/cartridge
• Rubber components
• Component process
• Filling operation/contractors

Device Development
Formulation
?

• Protein concentration
• Viscosity
• Excipient

• Device selection ?
• Device features specifications

Chang 2004
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Possible application injection devices. Why?
Device Development Activities

Device Design ?
Regulatory ?
Handling Studies
Clinical Acceptability
Device Performance ?
Risk Analysis
Syringe/cartridge physical property ?
Assembly
Product Quality ?
Chang 2004
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Possible application injection devices. Why?
Multiple Partners

•  Syringe/cartridge manufacturer (Shott?)
•  Rubber stopper and lined seal manufacturer
•  Device design/manufacturer
•  Filling contractor
•  Packaging machines contractors

?? Project management is complex ? ?? Efficient
open communication is the key ?
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Possible application injection devices. Why?
Device Development
?
?
Chang 2004
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Possible application injection devices. Why?
Summary

•  Biotechnology pharmaceutical markets are
  confronted to significant structural changes (cf.
  integration of injection device in the
  development process) ?
•  Multiple disciplines are required ?
•  Multiple partners make the development project
  complex and challenging ?

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Biopolymer substitution injection devices
Biomer (PHB) Properties
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Biopolymer substitution injection devices
PHB vs PP
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Biopolymer substitution injection devices
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Cost, energy, and emissions
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What can we bring you

• Methodology to identify sustainable materials
• Answer questions like How to assess the
  environmental impact of investments in new
  technologies?
• Sustainable analysis for CONVENIENT solutions
• EXAMPLE

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CONVENIENCE PRICE - SUSTAINABILITY
Home care trend
time
time
(WMS)
WMS
INFLUENCE
Polymer industries
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CONVENIENCE PRICE - SUSTAINABILITY
Home care trend
time
time
FIT
(WMS)
WMS
INFLUENCE
Polymer industries
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CONVENIENCE PRICE - SUSTAINABILITY
Home care trend
time
time
DOES NOT FIT
FIT
(WMS)
WMS
INFLUENCE
Polymer industries
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CONVENIENCE PRICE - SUSTAINABILITY
Home care trend
time
Time/RD
DOES NOT FIT
FIT
(WMS)
WMS
WMS
INFLUENCE
INFLUENCE
Polymer industries
BDP trend
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CONVENIENCE PRICE - SUSTAINABILITY
Home care trend
BDP
time
Time/RD
DOES NOT FIT
FIT
(WMS)
WMS
WMS
INFLUENCE
INFLUENCE
Polymer industries
BDP trend
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CONVENIENCE PRICE - SUSTAINABILITY
Home care trend
BDP
time
Time/RD
DOES NOT FIT
FIT
FIT
(WMS)
WMS
WMS
INFLUENCE
INFLUENCE
Polymer industries
BDP trend
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CONVENIENCE PRICE - SUSTAINABILITY
Home care trend
BDP
time
Time/RD
DOES NOT FIT
DOES NOT FIT
FIT
FIT
(WMS)
WMS
WMS
INFLUENCE
INFLUENCE
Polymer industries
BDP trend
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CONVENIENCE PRICE - SUSTAINABILITY
Home care trend
BDP
time
Convenience/green
(WMS)
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the future is at hand.Thank you
Pic. Sanden 2004
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Backup slides
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Reloading Drug Eluting Coatings
Concentration Gradient
Drug Molecules
Controlled Magnetic Field
Polymer Coating
Nanomagnetic layer
Substrate
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Surface Elution on Demand
Particle type A Drug A
Controlled Magnetic Field A
Controlled Magnetic Field B
Polymer Coating
Nanomagnetic layer
Substrate
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Guided Drug Delivery
Other options for targeting A - Direct injection
into tumor site B - Coating NMP with antibodies
to target tumor
Solid tumor
3 - Apply magnetic field to concentrate particles
in tumor
1 - Inject NMPs IV
2 Particles circulate in blood stream
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Backup slides
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(No Transcript)
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(No Transcript)
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PBCM Allows Technology Driven Sensitivity
Example Plasma Quench
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PBCM Allows Scenario Based Assessment of
Production Economics
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PBCM Quantifies Technological Hurdles Example
Cambridge Process
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Possible application injection devices.
?
The Basis of Competition in the Disk Drive
Industry
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• Contacts
• Novamont (Roberto Marengon)
• Dupont Biomax (Laurent Ziche)

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Sources of Information

• AAPS Drug Delivery Device Workshop Judy Y. Chang
  Genentech, Inc.May 20, 2004
• Eli Lilly and Company Innovation in Diabetes
  Care
• Dr Roger G Harrison PhD - CEO Antares
  presentation
• Assessing the Impact of Emergent Technologies.
  Randolph Kirchain MIT.
• Green Plastics Dr. R. Rangaprasad Dr. Y.B.
  Vasudeo
• Company Websites