General presentation RCPE

1. Research Center
Pharmaceutical Engineering (RCPE)
General overview
Partnering with RCPE
February 2013
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).

2. RCPE - Vision

3. RCPE - Mission
 To combine multi-disciplinary competence from chemical and
mechanical engineering, biotechnology, chemistry, pharmaceutical
technology and materials science to develop a coherent scientific
basis for a predictive understanding of process and product
development fundamentals
 In close interaction with Austrian and international pharmaceutical
and biopharmaceutical and technology manufacturer partner
companies to develop methods for designing, optimizing, scaling and
controlling the manufacturing of next-generation products
 To integrate targeted educational, gender-mainstreaming and human
resource development activities needed to implement science-based
approaches for design and optimization products, while protecting the
IP generated in the Center

4. RCPE - KEY FACTS
 Research Center Pharmaceutical Engineering GmbH – RCPE
 Independent Research Center for pharmaceutical
process and product development Joanneum Research:
 Located in Graz, Austria University of Graz: 15%
20%
 100% owned by research
institutions
 Our objectives:
Graz University of Technology:
 Develop Innovative science driven platform 65%
knowledge for process and product design & development
 Increase the sustainability profile reducing costs and time in
pharmaceutical development (e.g. enlarge the knowledge space)
 Create business advantages for our partners

5. A SUCCESS STORY...
 RCPE was founded on 1st of July 2008
 approx. 108 employees and researchers
 Average turnover: 7.1 M€
 12 Scientific Partners
 59 Industrial Partners
 Scientific Output:
 3 Patent granted
 12 Patent applications Office building with state-of-the-art laboratory facilities
 85 Publications refereed
 6 Bachelor theses
 39 Diploma theses
 6 Ph.D. Theses
 Spin-off (PRSG) has been launched (January 2012)
 Regulatory submission US and EU
 Spin-off (p[roombiotic]s) has been launched (July 2012)
 Innovation in cleaning verification of clean rooms (bioactive system)

6. Organizational Chart
General Assembly
Program Committee Scientific Advisory
Program Commission Supervisory / Strategy Board Board
CEOs
 Key Account  Strategic Leadership  Scientific Lead  Representation  Internal and external Consulting  IPRs
Deputy Director Reporting / Accounting
• Scientific Output
• Marketing / PR • Accounting / Controlling
• Coordination of International Scientific Appearance
• Human Resources • IT
• National and International Funding Applications
• External Reporting • Patents
• Infrastructure
Business Development & Scientific Operations
K1 NonK K1 NonK K1 NonK
ITT1: New Platform
Area I: Area II: Area III:
Technologies
Modeling and Prediction Product and Formulation Process Engineering
ITT2: Drug Quality and
Safety Technologies Advanced Modeling & Simulation Pharmaceutical Proteins Continuous Manufacturing
Material Science Dosage Form Development Process Development & Scale Up
ITT3: Personalized Medicine
e.g. Geriatrics
QbD/PAT
Infrastructure: Laboratory + Process Lab

7. RCPE – SCIENTIFIC AREA
Modeling and Product and Process
Prediction Formulation Engineering
 Pharmaceutical process modeling &  Pharmaceutical proteins  Continuous processing development and
simulation  Protein drugs implementation
 Granular flows  Oral & Inhaled Dosage form  Process Understanding & Control
 Fluid mixing and multiphase flows (including PAT)
 Nano technology
 Molecular simulations and structure  Process development & Scale up
 Novel drug delivery systems
optimization  Design Space and CPPs qualification
 Simplification on ODFs
 Material Science & Characterization
QbD/PAT

8. RCPE staff
 108 headcounts
(including Key Resarcher)
 average age: app. 30 years
 gender ratio: app. 50%
 14 nationalities
87%
Research &
Development

9. Educational profile
(Master, PhD)
18%
Technical Physics
23% 23%
Biotechnology Others 29%
Mechanical Engineering
26 %
Other Academic 18%
9%
Informatics Programmes2 37 % Technical Chemistry
15%
Engineering1
Mathematics
15% 35%
Physics Chemical Engineering
15%
Chemistry
37 % Pharmaceutical Sciences
1 chemical engineering, electrical engineering, mechanical engineering, process engineering, software engineering, technical
chemistry, technical physics, …
2 biotechnology, chemistry, informatics, mathematics, microbiology, physics

10. PARTNERING WITH RCPE
 Independent R&D in the field of Pharmaceutical Engineering and Product
Development, from science to industrial qualified applications
 Large span of scientific support in research activities:
 Basic research and knowledge implementation (including literature review, initial
characterization, proof of concept)
 Extensive multi-year research programs for platform implementation (e.g. Hot melt extrusion
implementation process and product following QbD principles)
 Defined IPRs provide maximum benefit for industrial partners
 Long-term strategic partnership (different business models available for partner`s
evaluation)
 Highly lean process to activate project/collaborations
 Project plan defined bilaterally and the project can be started immediately
 Established scientific and academic network
 Consolidated partnerships with industrial partners
 Equipment vendors (e.g. implementation of innovation in cps filling including Material Science)
 Specialty Pharma (e.g. HME implementation of innovative design of process including MS)

11. Collaborating with RCPE
 Benefits for RCPE’s partners
o Confidentiality ensured
o IPR belong to industrial partner
o Direct and transparent communication
o Proven scientific expertise
o Reliable data/results
o Effective support on implementation of platform knowledge - scientific quality and scientific
mentorship
o Flexibility in tailoring the team and in tailoring the desired level of integration
o Scientifically focused team working on strategic tasks (e.g. RCPE focus on science, industrial
partners focus on application to its pipeline)
o Industrial partner’s scientists exposed in a structured way to mechanistic approaches

12. PARTNER STRUCTURE
Industrial partners: Scientific partners:
Associated partners:

13. Scientific field and clusters
 Continuous manufacturing (secondary and primary)
 Cont blending
 Cont feeding (e.g. Low dose)
 Extrusion (HME, IM, WE)
 Particle Engineering
 DPI
 Spray Drying particle formation
 Nanoparticles
 Personalized Medicine
 E.g. Pills on paper
 E.g. RFID (microchip, digestible micro chip)
 RCPE is member of Geriatric Medicine Society
 No pofit collaboration with University College London, School of Pharmacy
 Simplification in secondary processes and ODFs
 E.g. Simple formulation in HG cps
 E.g. Continuous manufacturing process with real-time-release (assessment of economics involved in the transformation)
 E.g. RTR applied on powder blending DC (original process blending , HSWG, drying, blending, tabletting)
 Bio enhanced systems (biopharmaceutics)
 Nano systems
 Amorphous
 Wettability enhancement

14. CONTACT
Prof. Dr. Johannes G. Khinast Dr. Thomas K. Klein
Director - Science Director - Business
Contacts: Contacts:
e-mail: khinast@tugraz.at e-mail: thomas.klein@rcpe.at
phone: +43/316/873/7978 phone: +43/316/873/9700
Massimo Bresciani Dr. Simon Fraser
Director Scientific Operations Deputy Director
Contacts: Contacts:
e-mail: massimo.bresciani@rcpe.at e-mail: simon.fraser@rcpe.at
phone: +43/316/873/30915 phone: +43/316/873/9707
Inffeldgasse 13
A-8010 Graz