Catarina Duarte

Directora Unidade de Nutracêuticos

Fórum Estratégico de Oeiras Valley 25 de Outubro - 9h30

Universidade Nova de Lisboa (UNL)

Instituto de Tecnologia Química e Biológica (ITQB)

Faculdade de Ciências e Tecnologia (FCT)

Instituto Gulbenkian de Ciência (IGC)

16 Portuguese Companies as Partners:

Pharmaceutical/ Health Sciences

Agro-forestry, pulp and paper

Agroindustry

Oeiras Campus of ITQB, IGC, IBET (Lab.

Associado)

Over 30.000m2, 800 scientists and

researchers of which 200 Ph.D.’s.

70 personnel directly paid by IBET

16 x 75m2

fully

equiped

laboratories

2.400 m2 Pilot Plant plus

cGMP GenIBET

(45%IBET)

Human resources:

20 PhD 42 graduate researchers

5 Technicians 8 administratives

• Contract Research Projects

• “Umbrella Research Contracts” plus per project based contracts

• Joint Research for Advanced Training (e.g. PhD Students, technicians publications submitted after both parties approval)

FLEXIBILITY & CONFIDENTIALITY

SPECIFIC NEEDS

Range of Services @ iBET

iBET’s Mission

To foster the competitiveness of our customers and partners, by creating wealth out of knowledge of Chemistry, Biochemistry and Biology

Bioprocess Development for:

Recombinant proteins

DNA, VLP’s, retroviral, lentiviral and adenoviral vectors

Diagnostics and vaccine candidates for AIDS, Rotavirus, Leishmania,

Peste des petits ruminants

Alternative model systems as tools for biochemical and

pharmacological studies,

Cell handling based on surface controlled

differentiation,

3D culture systems, primary cultures and stem cells –

hESC, adult stem cells (e.g. MSC), iPS

Bottom up systems biotechnology,

Scaled down tools for DSP.

Animal Cell Technology

• Cell Bioprocesses Lab

headed by Paula Alves

• Engineering Cellular Applications Lab

headed by Manuel Carrondo

• Cell Line Development and Molecular Biology Lab,

headed by Ana Sofia Coroadinha.

ACT TEAM

10 senior researchers and post-docs

4 technicians (Bioreaction, dowstream and analytics, lab manager

18 PhD students plus 4 MSc Students

4 research assistants

Animal Cell Technology

Pilot Plant

Biopharmaceutical Products

Supercritical Fluid Extraction

Vaccine Process Development

Diagnostics

Supply of purified proteins for

structure function (Chrystallographic

and Proteomic)

Track-record

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Pilot Plant

Main Equipment

Fermenters up to 400L 32 port MS for off gas analyses Centrifuges (disc and solid bowl) High pressure homogenizers (1200 bars) Micro/ultra filtration unit Freezedryer (1,5 m²) Thin-film evaporator (40L/h flow rate) Rotavapor (50L) Crystallizer, settler and single-layer process filter (120L) Liquid-liquid extractor (2 stage counter current cross flow) Preparative and pilot scale chromatography UBICON supervisor and process control system Supercritical fluid extraction units (for solid and liquid extraction)

CLIENT Process development

Process scale-up

Cell banking and storage

Assay development and validation

GMP Manufacturing

Viral clearance

Quality Control

Cell line development and optimization

www.genibet.com

A cGMP Bridge to Personalized Medicine

Facilities

Virus Unit

QC Labs

Cell Culture Fill and Finish

Bacterial Unit

3D protein structure determination (X-Ray, NMR)

Limited Proteolysis for protein construct design

Differential Fluorimetry Assays (Thermofluor) for protein

stability studies

Molecular modeling of protein structures, protein-ligand

and protein-protein interactions

Proteomics

Proteomics

Collaboration with Bayer Pharmaceuticals

Collaboration with Merck Serono

Protein Chemistry Molecular Biology

Structural Biology Molecular Modelling/ Structural

Analysis

Bioinorganic Chemistry Thermodynamics and kinetics

characterization of Redox and metalloproteins

Track record

Current Activities

Analytical Services Unit

The Unit is certified by the

INFARMED and IPQ as compliant

with GLP.

Joint department of IBET and ITQB under

the executive management of IBET

Analytical development, validation and

testing of chemicals and biologicals as well

as studies on candidate pharmaceutical

products according to OECD Good

Laboratory Practices Principles

Analytical Laboratory Chromatographic (HPLC and GC with several

detectors) and electrophoretic methods for

pharmaceutical, agro and chemical industry and

academia.

Cell Based Assays and Microbiology Laboratory in vitro potency assays, protein quantification, molecular biology analysis

(GMOs in food and feed and other) and detection and quantification of

impurities or contaminants in pharmaceutical. Development of Cell Based

Assays.

Mass Spectrometry Laboratory Development and validation of analytical methods as well as routine

analysis for a broad range of chemical compounds, from small organic

and organometalic compounds to peptides, oligosaccharides, nucleotides

and proteins.

Analytical Services Unit

Nutraceuticals and Delivery

main activities :

•Green Processes for developing health promoting products

•Supercritical Fluid Technology – application to extraction and

precipitation processes

•Materials Processing – particle formation, hybrid structures and

microbubbles, nano/micro encapsulation and impregnation

projects include:

•Development of Drug Delivery Systems

•Functional Products and Nutraceuticals Formulation

•Health claims assessment (in-vitro bioactivity evaluation

Production of natural

extracts/Isolation of bioactive

ingredients

Green sustainable processes

High pressure and supercritical fluid technology

Membrane Filtration

Adsorption process (with macroporous

resins)

Conventional Extraction (with

biocompatible solvents)

(that reduce or eliminate

the use or generation of

hazardous substances Bioactive rich fractions (e.g. polyphenols, carotenoids, phytosterols, terpenes,...)

Natural colours

Natural flavours

Natural preservatives

Nutraceuticals and Delivery

23

Formulation/ Encapsulation

Increase Shelf

life and

stability of the

bioactive

Increase

solubility

Increase

bioavailaibity

Protect

against GIT

Increase the

bioactive

efficacy

“Conventional” Precipitation Techniques

Supercritical Fluid Technologies

Nutraceuticals and Controlled Delivery

Interface

Glicobiology

Supercritical Fluids

Biomathematics

Chiral Synthesys

Ionic Liquids

Contract, project, resources are time limited

Discovery

StructuralBiology/ Proteomics Bayer Berlin MS Darmstadt

Primary & Stem Cells CEVEC Köln Merck & Co., Rahway, NJ Astrazeneca, Göteburg Centocor, J&J NJ Cellon, Luxembourg

Mab’s Bayer Köln (Sat. Lab) Micromet Munich

Preclinical

Engineering Merck & Co., West Point, PA GlicoFi, New Hampshire Lonza, UK Novartis, Switzerland Leti, Spain Sartorius-Stedim, Göttingen

Biologicals & ATMP’s Bayer, Wuppertal MS Darmstadt, Geneve Merck & Co., West Point, PA Merck & Co., Rome (IRBM) Genethon, Paris Apceth, München Alloksys, Bunnik (NL) Sanofi Pasteur, Lyon

Projects With Foreign Companies

Plant Biotech – BASF, Bayer Crop Sciences