rcpe partnering 13_00v01
DESCRIPTION
General presentation RCPETRANSCRIPT
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).
Research Center
Pharmaceutical Engineering (RCPE)
General overview
Partnering with RCPE February 2013
RCPE - Vision
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
RCPE - KEY FACTS
Research Center Pharmaceutical Engineering GmbH – RCPE
Independent Research Center for pharmaceutical
process and product development
Located in Graz, Austria
100% owned by research
institutions
Our objectives:
Develop Innovative science driven platform
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
Joanneum Research:
15%
Graz University of Technology:
65%
University of Graz:
20%
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
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)
Office building with state-of-the-art laboratory facilities
Scientific Lead Internal and external Consulting
Key Account
CEOs Strategic Leadership Representation
IPRs
Organizational Chart
General Assembly
Supervisory / Strategy Board
Program Committee
Program Commission
Reporting / Accounting
Deputy Director
• Scientific Output
• Coordination of International Scientific Appearance
• National and International Funding Applications
• Infrastructure
Infrastructure: Laboratory + Process Lab
ITT2: Drug Quality and
Safety Technologies
Area I:
Modeling and Prediction
Area II:
Product and Formulation
Area III:
Process Engineering
NonK NonK NonK K1 K1 K1
Advanced Modeling & Simulation
Material Science Dosage Form Development
Continuous Manufacturing
Business Development & Scientific Operations
ITT1: New Platform
Technologies
ITT3: Personalized Medicine
e.g. Geriatrics
• Marketing / PR
• Human Resources
• External Reporting
• Accounting / Controlling
• IT
• Patents
QbD/PAT
Process Development & Scale Up
Pharmaceutical Proteins
Scientific Advisory
Board
RCPE – SCIENTIFIC AREA
Pharmaceutical process modeling &
simulation
Granular flows
Fluid mixing and multiphase flows
Molecular simulations and structure
optimization
Material Science & Characterization
Pharmaceutical proteins
Protein drugs
Oral & Inhaled Dosage form
Nano technology
Novel drug delivery systems
Simplification on ODFs
Continuous processing development and
implementation
Process Understanding & Control
(including PAT)
Process development & Scale up
Design Space and CPPs qualification
Modeling and
Prediction
Product and
Formulation
Process
Engineering
QbD/PAT
RCPE staff
108 headcounts
(including Key Resarcher)
average age: app. 30 years
gender ratio: app. 50%
14 nationalities
87%
Research &
Development
Educational profile
(Master, PhD)
37 %
Engineering1
37 % Pharmaceutical Sciences
26 %
Other Academic
Programmes2
1 chemical engineering, electrical engineering, mechanical engineering, process engineering, software engineering, technical
chemistry, technical physics, … 2 biotechnology, chemistry, informatics, mathematics, microbiology, physics
29%
Mechanical Engineering
35%
Chemical Engineering
18%
Technical Physics
18%
Technical Chemistry
23%
Others
15%
Physics
23%
Biotechnology
9%
Informatics
15%
Chemistry
15%
Mathematics
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)
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
Industrial partners: Scientific partners:
Associated partners:
PARTNER STRUCTURE
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
CONTACT
Inffeldgasse 13 A-8010 Graz
Dr. Thomas K. Klein Director - Business
Contacts:
e-mail: [email protected] phone: +43/316/873/9700
Prof. Dr. Johannes G. Khinast Director - Science
Contacts:
e-mail: [email protected] phone: +43/316/873/7978
Dr. Simon Fraser Deputy Director
Contacts:
e-mail: [email protected] phone: +43/316/873/9707
Massimo Bresciani Director Scientific Operations
Contacts:
e-mail: [email protected] phone: +43/316/873/30915