Fórum OV - IBET
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Transcript of Fórum OV - IBET
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
Ce
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C
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uga
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Mic
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Ult
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Pu
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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