Company Presentation

RCPE GmbHRCPE GmbHMay 2010

K1 Competence Center - Initiated by the Federal Ministry of Economy, Family and Youth (BMWFJ) and the Federal Ministry of Transport, Innovation and Technology (BMVIT). Funded by FFG, Land Steiermark and Steirische Wirtschaftsförderung (SFG).

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RCPE - KEY FACTS 1/2

Competence Centers are highly successful technology policy initiatives in Austria (currently 40+ centers with 1500+ researchers)Obj ti f C t C tObjectives of Competence Centers:

Cooperation between science and industryA hi i j i t t t i t l l hAchieving joint strategic top-level research Initiate new scientific and technological developments

Ne Competence Center la nched on the 1st of J l 2008New Competence Center launched on the 1st of July 2008: Research Center Pharmaceutical Engineering GmbH (RCPE) Total volume: approx €30 Mio ($42 Mio) for 7 yearsTotal volume: approx. €30 Mio ($42 Mio) for 7 yearsTimeframe: 7 years (extension possible)L t d i G A t iLocated in Graz, Austria

RCPE - KEY FACTS 2/2

RCPE is a non-profit limited liability company (GmbH)

100% owned by research institutions (Graz University of Technology: 65%, University of Graz: 20%, Joanneum Research: 15%)

RCPE projects are partially funded by the Austrian Research PromotionRCPE projects are partially funded by the Austrian Research Promotion Agency (national funding institution for applied industrial research in Austria) with 32.67% and by the province of Styria with 16.33%

Total public financing of 49%

min 26% cash5% i tifi

Joanneum Research: 15%

University of Graz: 20%min. 26% cash5% scientific

max. 20% in-kind

49% fundings

in kind

Graz University of Technology: 65%

Project funding overview Ownership structure

RCPE - KEY BENEFITS

RCPE provides independent R&D in the field of pharmaceutical i i b id i th b t i d i d t i l li tiengineering, bridging the gap between science and industrial applications

Defined IPRs provide maximum benefit for industrial partners

Long term cooperation with the RCPE possibleLong-term cooperation with the RCPE possible (funding period of 7+ years)

Diversity in research activities: small preparatory studies (literature review, initial measurements, proof of concept) up to extensive multi-year research programs are possible

Only 26% cash contribution required in joint research projectsOnly 26% cash contribution required in joint research projects

No time-consuming project application procedures; project work plan can be defined bilaterally and the project can be started immediately

RCPE can provide additional scientific partners if expertise is required

RCPE can provide additional industrial partners if industrial cooperation i d i d d/ f j t t h iis desired and/or for project cost-sharing

RCPE - TOPICS

We are interested to add YOU as Company or Scientific Partnerf ki t th th f ll i t ifor working together on the following topics:

Simulation toolsParticle technology (Coating, extrusion, melt extrusion, drying, etc.)Bioprocessing and bioreactorsPrinting of drugsPrinting of drugsProcess Analytical Technology (PAT)Continuous processingProtein manufactureMicroparticle synthesisQuality by Design (QbD)Quality by Design (QbD)

New areas and topics are welcome

RCPE - AREAS OF THE CENTER

AREA I –SELECTION OF CURRENT PROJECTSSELECTION OF CURRENT PROJECTS

MIXING & DISSOLUTION PROCESSES

MICROPARTICLES SYNTHESIS

VIRTUAL QUALITY-BY-DESIGN

AREA II –SELECTION OF CURRENT PROJECTS

PROTEIN PROPERTIES & AGGREGATION

SELECTION OF CURRENT PROJECTS

INTERACTION PACKAGING MATERIALS & PHARMACEUTICAL FORMULATIONSPHARMACEUTICAL FORMULATIONS

NANOPARTICLES

AREA III –SELECTION OF CURRENT PROJECTS

CONTINUOUS MANUFACTURING

SELECTION OF CURRENT PROJECTS

PRINTABLE FORMULATIONS

Carrier

API

CLEANROOMS

ONLINE MONITORING - PAT

SINGLE POINT OF CONTACT

CustomerCustomer

One stop shop for…RCPE connects customers to…

Research Projects

Funded and Contractual

Graz University of Technology, University of Graz, Joanneum Research, …

Research Facilities

j

K1

Research

ServicesIndustrial Partners

K1 Services

OUR PARTNERS 01.07.08

OUR PARTNERS TODAY

RCPE Analytics

FT‐NIR/MIRPerkinElmer

Raman PerkinElmer

FT‐IR Bruker VERTEX

React IR ASI ReactIR 1000

SWAXS Hecus S3‐Micro

Helos SympatecLaser diffraction

QicPic SympatecSize and shapePerkinElmer 

Spectrum 400PerkinElmer 

RamanStation 400Bruker VERTEX  ASI ReactIR 1000 Hecus S3 Micro Laser diffraction 

size analysisSize and shape image analysis  

HPLCHP‐Agilent 1090

GC PerkinElmer 

DTALyotherm 

DSCShimadzu DSC‐50

EVK HeliosNIR Imaging

ZetasizerMalvern

Krüss EasydropContact angle 

Clarus500 NanoZS measurement

RheometerAnton Paar Physica 

MicroscopeLeica DM4000 

PIV cameraMotionScope M3

Freeman FT4Powder rheometer

Friability TestingCopley

Kern MLS_NMoisture analyzer

Pfrengle´s trickle test

MCR 300 DFC290 camera  AS 400 DIN/ISO 4324

RCPE Process Equipment

Extrusion System Batch Fluid Bed System Compaction SimulatorLaboratory Tablet PressExtrusion SystemZSK 18

Coperion

Batch Fluid Bed System GPC G1

Glatt Process Technology

Compaction SimulatorSTYLCAM 200R

MedelPharm

Laboratory Tablet Press102i

Fette Compacting

SIMULATION TOOLS

Multiphase flow

CFD (Computational Fluid Dynamics)

Particle flow

DEM (Discrete Element Method)CFD (Computational Fluid Dynamics) DEM (Discrete Element Method)

Spray drying/ granulation Spray and coating Bubbly flowsBlending Coating

Software: EDEM, RPDMixing

Molecular dynamicsMD (Molecular Dynamics)MD (Molecular Dynamics)

Room flow

Softwares: FIRE OpenFOAM Software: MOESoftwares: FIRE, OpenFOAM Software: MOE

OVERALL RCPE BUDGET AND FUNDING

16,7 Mio.€f ffor four years

Scientific 

Partners 46%

Partners 

5% 

16 33%

Province of Styria

Funding 54%

16,33%

54%

32,67%,

IPRS AND FUNDING MODEL

Defined IPRsFull IPR to industry partners

Gratuitous non exclusive timely unlimited non transferableDefined IPRs(Intellectual Properties Rights)

Gratuitous, non-exclusive, timely unlimited non-transferable right of use to RCPE

Exploitation and utilization rights to RCPE after 12-24 months

Project Financing (Example)

Details must be singularly clarified in cooperation contract

P j t V l € 500 000Project Volume € 500.000,-

Funding 49% € 245.000,-

Inkind University 5% € 25.000,-

min. 26% cash5% scientific

max. 20% in kind

Cash Industry 26% min. € 130.000,-

Inkind Industry 20% max. € 100.000,-49% fundings

in-kind

3 Industry Partners:Cash per each industry partner € 43.333,-

Inkind per each partner € 33 333 -

2 Industry Partners:Cash per each industry partner € 65.000,-

Inkind per each partner € 50 000 - Inkind per each partner € 33.333,Inkind per each partner € 50.000,

SUCCESS STORY

RCPE was founded on 1st of July 2008app. 65 employees3 new Scientific Partners and 18 new Industrial Partners4 patents

A t f l i l t f d i h ti l d tA system for analyzing a granulate for producing a pharmaceutical productA system and method for manufacturing a medicationMethods and compositions for biologically controlling microbial growth on l i tclean room equipment

Synthetical Nucleic-Acid-ParticleWorking Group at Rutgers University in New Jersey, USA established (since 15th of April 2009, three employees)One new Business Unit (RCPS) has been launched

THE PROCESS ENGINEERING CENTER

Office building with state-of-the-art laboratory facilitiesStart of construction: 2009Scheduled for completion: 2011Footprint: 1000 m² / 7 stories + basementp

CONTACT

Prof. Dr. Johannes KhinastScientific Director

Contacts:e‐mail: [email protected].:      +43/316/873/7978

Dr. Thomas K. KleinBusiness Director

Inffeldgasse 21a/II A‐8010 Graz

Business Director

Contacts:e‐mail: [email protected] : +43/316/873/9700tel.:      +43/316/873/9700