+ All Categories
Home > Documents > Research Center Pharmaceutical Engineering GmbH

Research Center Pharmaceutical Engineering GmbH

Date post: 09-Apr-2022
Category:
Upload: others
View: 4 times
Download: 0 times
Share this document with a friend
22
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
Transcript

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)

Company Presentation6

Strategic

PartnershipsMedium-term Engagements

Collaboration Modes with RCPE

Company Presentation7

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 Presentation8

Partner StructureIndustrial Partners Scientific Partners

Supporting Partners

Company Presentation9

Organisational Chart

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)

Company Presentation21

Certified Excellence

Company Presentation22

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]


Recommended