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: thomas.klein@rcpe.at phone: +43/316/873/9700

Prof. Dr. Johannes G. Khinast Director - Science

Contacts:

e-mail: khinast@tugraz.at phone: +43/316/873/7978

Dr. Simon Fraser Deputy Director

Contacts:

e-mail: simon.fraser@rcpe.at phone: +43/316/873/9707

Massimo Bresciani Director Scientific Operations

Contacts:

e-mail: massimo.bresciani@rcpe.at phone: +43/316/873/30915