Research Center Pharmaceutical Engineering GmbH
Transcript of Research Center Pharmaceutical Engineering GmbH
RCPE is a K1 COMET Centre within the COMET – Competence Centres for Excellent Technologies
programme. The COMET programme is operated by the Austrian Research Promotion Agency (FFG) on
behalf of the Federal Ministry for Transport, Innovation and Technology (BMVIT) and the Federal Ministry for
Digital and Economic Affairs (BMDW). Our projects are also funded by Land Steiermark and the Styrian
Business Development Agency (SFG).
Research Center Pharmaceutical Engineering GmbH
Company Presentation
Key Facts:
Independent research center for pharmaceutical process & productdevelopment
Located in Graz, Austria
100% owned by research institutions
Our Mission:
Develop Innovative science driven platform knowledge for process andproduct design & development
Increase the sustainability profile reducing costs and time in pharmaceuticaldevelopment (e.g. enlarge the knowledge space)
Create business advantages for our partners
Company Presentation2
A Success Story…
Founded on 1st of July 2008
150 employees and researchers
Turnover 2018/2019: € 11.8 M
> 25 Scientific Partners, > 130 Industrial Partners
Scientific Output*: 7 Licenses granted 7 Patents granted, 26 Patent applications 464 Conference talks refereed 385 Papers refereed 21 Bachelor, 145 Diploma/Master, 50 PhD Theses
Company Presentation3
*as per 30th June 2019
Regulatory submission US and EU
Innovation in cleaning verification of clean rooms (bioactive system)
Multiphysically simulations, development of software solutions
Tools for sample preparation for thermoplastic materials
4 Spin-Offs
Company Presentation4
Partnering with RCPE
Independent R&D in the field of Pharm. Engineering & 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 characterisation, proof of concept)
Extensive multi-year research programmes for platform implementation (e.g. Hot melt extrusion implementation process and product following QbD principles)
Defined IPRs provide maximum benefit for industrial partners
Company Presentation5
Partnering with RCPE
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)
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Strategic
PartnershipsMedium-term Engagements
Collaboration Modes with RCPE
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Existing
Capabilities
Companies / Business Partners
Research Center Pharmaceutical Engineering
Existing
Capabilities
Resources &
New Capabilities
Needs, Capabilities,
ResourcesResources
Immediate
Needs
Persisting
Needs
Services &
New Knowledge
Needs, Capabilities,
ResourcesServices
Short-term Engagements
Company Presentation10
Modelling & Prediction Advanced Products &
Delivery
Process &
Manufacturing Science
Continuous Flow
Synthesis & Processing
• Process simulation
• Modeling of granular and
multi-phase flows
• Software development
• Electronic, atomistic and
molecular simulations
• Advanced material
modeling
• Advanced dosage forms
(oral & inhaled)
• Nano technology and
particle engineering
• Physicochemical profiling
• Novel drug delivery
systems & female health
• Personalised medicine
• Biopharmaceutics
• Process development and
scale up
• Process control
• Process analytical
technology (PAT)
• Continuous Processing
• Design Space & CPPs
Qualification
• Novel Flow Chemistry
• Designer Reagents for Flow
• Reaction and Process
Engineering
• PAT & Process Simulation
• Process Integration
• API Synthesis in Flow
Area I Area II Area III CC FLOW
Company Presentation11
Central Research Themes
Predictive
Tools
Platforms &
Workflows
Advanced
Quality
Control
Bio-
pharmaceutics
High-Fidelity
Simulation
Advanced
Material
Science
Standardised
Workflows
Hot-Melt
Extrusion
Particle
Engineering
Printing
Continuous
Production
Advanced
Process
Control
X-Ray
Hyperspectral
Imaging
Novel
Technology
OCT
22.01.2020
Predictive Tools
Company Presentation12
Commercial DEM-CFD Code XPS up to 108 particles
SPH for multi-phase modeling (e.g., extruders)
Molecular modeling (e.g., prediction of physical/chemical
stability)
Process modeling and process control
Predictive
Tools
Bio-
pharmaceutics
High-Fidelity
Simulation
Advanced
Material
Science
Advanced PBPK models for oral and inhalative delivery
Novel BP models (e.g., buccal/vaginal Frantz cells)
Materials characterisation facility (e.g., micromeritics,
structure, chemical identity)
Powder processing pilot plant (feeding to tableting)
Platforms & Workflows
Company Presentation13
Continuous processing pilot plant (DC, Consigma 25, HME)
for APIs up to OEB 4.
Hot-melt extruders (8mm – 27mm), including downstream
Novel scale-up approaches
Crystallisation, spray drying (small to pilot scale), melt
congealing, taste masking
Continuous particle design (e.g., shape modification)
Workflows for poorly-solubles formulation and continuous
processing with minimum material
2D and 3D printing supporting
Platforms &
Workflows
Standardised
Workflows
Hot-melt
Extrusion
Particle
Engineering
Printing
Continuous
Production
Advanced Quality Control
Company Presentation14
Optical coherence tomography to aid in the development of
coated drug delivery forms
Optical coherence tomography to monitor coating processes
in real time (pellets, beads, tablets, etc.)
Hyperspectral imaging for the 100% control of oral delivery
forms (NIR, Raman)
Fast Terahertz monitoring for powder density control
Soft sensors, MPC, disturbance fast forward, and other
advanced process control approaches for achieving highest
product quality
Advanced
Quality
Control
Advanced
Process
Control
X-ray
Hyperspectral
Imaging
Novel
Technology
OCT
Company Presentation15
Single Point of Contact
Customer
Research facilities
(e.g., melt extrusion system, cps development and
filling, tablet forming/ coating, …)
One stop shop for…
Research
projects
K1
Funded and
contractual
research
NonK
Services
RCPE connects customers to…
Graz University of Technology, University of Graz,
Joanneum Research, Heinrich Heine University,
Rutgers University, University of Cambridge, …
Preferred partner
Regulatory submission, clean room technology, GMP lab
Industrial partners
What is a K1 project?
Partially funded by Austrian Federal Funding Agency
Minimum three year duration
Must involve a minimum of two industrial and one scientific partner
Project partners contribute cash and in-kind payments
Project topics are aimed at research and must have high level scientific output
Scientific results must be published in peer reviewed journals or at relevant industry conferences
Partner participation governed by Project Agreement which details scientific areas of interest, expected outcomes, financial contributions, IP rights etc
Company Presentation
Embedded in the Academic Environment
Access to expertise from a wide range of different scientific academic fields e.g.: Chemical Engineering, Mechanical Engineering, Chemistry, Physics, Material
Science, Pharmaceutical Science, Biotechnology, Mathematical Science, Computer Science, Electrical Engineering, Medical Science, Molecular Bioscience
Access to equipment and infrastructure of local and international partners This includes the equipment available in all Institutes as well as all associated
business units (e.g. the Austrian Centre for Electron Microscopy and Nanoanalysis, http://www.felmi-zfe.tugraz.at/)
Access to students and (post) graduates Possibility to choose students and (post)graduates from a pool of candidates with the
best academic background, and engaging them in diploma theses (6 months FTE), dissertations (3-4 years FTE work) and on a Post-Doc level
Company Presentation17
Company Presentation18
RCPE Staff
150 employees
average age: 33,5 years
gender ratio: 37% female, 63% male
20 nationalities
Individually planned trainings, coaching & development schemes
Company Presentation19
Educational Profile
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
Company Presentation20
Exceptional Infrastructure
New building with of state-of-the-art
facilities
Pharma standard clean rooms
Occupational Exposure Banding
Handling of highly potent substances
Negative pressure and decontamination air locks
One dedicated VEXAT room
Extensive selection of equipment (different scales)
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Contact
Dr. Thomas KleinBusiness Director / CEO
Tel.: +43 316 873 30900
Mail: [email protected]
Prof. Dr. Johannes KhinastScientific Director / CEO
Tel.: +43 316 873 30400
Mail: [email protected]