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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) 30.000m2, 800 scientists and researchers of which 200 Ph.D.’s.  Over

 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


iBET’s Mission

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

Range of Services @ iBET


Animal Cell Technology  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


Pilot Plant Track-record  Biopharmaceutical Products  Supercritical Fluid Extraction

 Vaccine Process Development  Diagnostics  Supply of purified proteins for structure function (Chrystallographic and Proteomic)


Centrifugation

Micro / Ultra filtration

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)

Cell disruption

Main Equipment

Purification

Pilot Plant


Process development

CLIENT

Process scale-up

Quality Control

Viral clearance

GMP Manufacturing

Cell line development and optimization Cell banking and storage

Assay development and validation


Facilities A cGMP Bridge to Personalized Medicine

Virus Unit Bacterial Unit QC Labs

Fill and Finish

Cell Culture

www.genibet.com


Proteomics

 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

Current Activities  Collaboration with Bayer Pharmaceuticals  Collaboration with Merck Serono

Track record  Protein Chemistry

 Molecular Biology

 Structural Biology

 Molecular Modelling/ Structural Analysis

 Bioinorganic Chemistry characterization

 Thermodynamics and kinetics of Redox and metalloproteins


Analytical Services Unit 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 The Unit is certified by the INFARMED and IPQ as compliant with GLP.


Analytical Services Unit 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.


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

Nutraceuticals and Delivery

High pressure and supercritical fluid technology

Conventional Extraction (with biocompatible solvents)

Green sustainable processes (that reduce or eliminate the use or generation of hazardous substances

Membrane Filtration Bioactive rich fractions (e.g. polyphenols, carotenoids, phytosterols, terpenes,...)

Adsorption process (with macroporous resins)

Natural colours Natural flavours

Natural preservatives


Nutraceuticals and Controlled Delivery Supercritical Fluid Technologies

Increase Shelf

“Conventional� Precipitation Techniques

life and stability of the

bioactive Increase the

Increase

bioactive

Formulation/ Encapsulation

efficacy

solubility

Protect

Increase

against GIT

bioavailaibity

23


 Biomathematics  Glicobiology

 Supercritical Fluids  Chiral Synthesys  Ionic Liquids

Contract, project, resources are time limited

Interface


Projects With Foreign Companies

Discovery

Preclinical

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

StructuralBiology/ Proteomics Bayer Berlin MS Darmstadt

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

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

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

Plant Biotech – BASF, Bayer Crop Sciences



Fórum OV - IBET