www.cirm-ulg.be
Member of
CIRM - Avenue de l’Hôpital 1 - B36 - 4000 Liège (Belgium)
Center for Interdisciplinary Research on Medicines
University of Liège
C I R M
CIRM - Quality in Service
Scope : drug
Any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological,
immunologi-cal or metabolic action with a view to restoring, correcting
or modifying physiological functions or to make a medical diagnosis (DIRECTIVE 2011/62/EU).
Quality system
The laboratories are covered by an ISO 17025 or ISO 15189 accreditation, or by FAMHP agreement.
They work in accordance with their quality system (proce-dures, equipment qualification, internal audits, etc).
The laboratories also benefit from the expertise of research
CIRM - Analytics
Services
Development, robust optimisation and validation of
analy-tical and bioanalyanaly-tical methods according to ICH/FDA gui-delines
For
• Purity testing of active principal ingredients • Quality control of pharmaceutical formulations
• Long- or short-term stability studies of API and pharma-ceutical forms
• Survey studies of poor quality medicines
• Determination of synthesis by products, impurities and degradation products
• Pharmacokinetic, bioequivalence and bioavailability studies
In the framework of
• Development of monographs for the European Pharma-copoeia
• Consulting and expertise reports
• Support for implementation of drug testing laboratories and their respective quality sytems (ACP-UE CUD) • Educational trainings (separative methods, quality
assu-rance and quality management)
Equipments
• LC, GC, CE, SFC, LCI
• UV, DAD, LIF, ELSD, MS, MS/MS • NMR
• AAS, IR, NIR, Raman, Raman confocal microscopy • Elemental analysis
• SPE, head space, SFE, microwaves • DSC • Microfluidic systems
Regulatory
FAMPH (ISO 17025)Contacts
Marianne Fillet [email protected] Philippe Hubert [email protected]CIRM - Clinical Biology
Services
Toxicology•
Clinical toxicology•
Industrial toxicology•
Risk assessment for the general population exposed to many chemicals•
Forensic toxicology expertises•
REACH Biocides evaluation•
Development of personnalized drug monitoringClinical Chemistry
• Constitution of clinically characterized blood banks • Analytical and clinical validation of biomarkers and
new assays
• Oxidative stress evaluation
• Scientific and clinical expertises in specialized fields : bone markers, allergology, oxidative stress, hormonolo-gy and endocrinolohormonolo-gy, cardiac markers, autoimmunity
Regulatory
ISO 17025 and ISO 15189
Equipments
• HR-LC-MS • LC-MS/MS • UPLC-MS/MS • UPLC-DAD • HS-GC-MS• ICP-MS (with collision cell) • HPLC-MS
• GC-FID • GC-MS/MS • FIMS
• Luminometer (Magpix)
• Automates for immunochemistry from different com-panies (Roche, Abbott, IDS, DiaSorin, Beckman, bioMé-rieux,…)
Contacts
Etienne Cavalier [email protected] Corinne Charlier [email protected]CIRM - Clinical Pharmacology
Services
Setup and conducting of clinical trials:
•
Different types of trials: Phases 0 to IIa- Exploratory Clinical Trial (eCTA)
- First administration to Human (First-In-Man) - Bioequivalence
- Bioavailability (pK, pD) - Cardiac safety (QTc) - Food interaction - Drug interaction
- Proof of concept (Efficacy/Tolerance)
•
Different designs of trials:- Double blinded; open
- Single dose, multiple doses, ascending dose - Parallel arms; cross-over
•
Different kinds of drugs:- Chemical active substances
- Biotechnology products (e.g. monoclonal antibodies) - Phytotherapy
Regulatory
FAMPH (GCP, GMP Early Phase)
Equipments
For volunteer’s security:
•
30 Hospital beds•
Nurse call system•
Automatic defibrillator•
Resuscitation trolleyFor routine techniques:
•
Material for biological samples collection (blood, urine and feces)•
Vital signs measurements (thermometer, sphygmomanometer)•
ECG and cardiac monitoring•
Telemetry (cardiac and vital signs monitoring)For specific techniques:
•
Infusion pump and syringe pump•
Automatic blood glucose dosage for•
Hyperglycaemic/ Euglycaemic clamp•
GGI (Graded Glucose Infusion)•
Privileged access to the technical expertise and material of the Academic Hospital of Liege.Contact
André ScheenCIRM - Drug Formulation
Services
•
Formulation of dosage forms (solid, liquid and semi-solidformulations) including for example tablets, granules, implants, powders for inhalation, solutions, suspensions, emulsions, creams, liposomes, nanoparticles,...
•
Characterization of solid dosage forms :- In-vitro dissolution (USP methods 1,2 and 3) - Hardness, friability and disintegration time (Eur. Pharm.) - Compression properties of powders
•
Physical characterization of materials :- Flow properties - Particle size distribution - Thermal analysis - Viscosity
- Water content
•
Consulting and expertise reportsEquipments
•
Mixers and high-shear mixers/granulators•
Dryers (fluid-bed dryer, spray-dryer, freeze dryer)•
Tablet presses (excenter, rotary)•
Coated pans (perforated pans)•
Fluid-bed coating equipment•
Extruder/spheronizer•
Freeze dryer•
Super critical fluid equipments•
Hot melt extrusion (equipment for (co)-extrusion equip-ped with probes for vibrational spectroscopy•
Laminar flow station•
Automated in vitro dissolution testing•
MLI, Twin impinger•
Laser diffraction•
Zeta potential measurement•
Photon correlation spectroscopy•
DSC equipment•
Texturometer•
Viscosimeter•
Osmometer•
Franz cellsRegulatory
FAMPH (ISO 17025)Contact
Brigitte Evrard [email protected]CIRM - Drug synthesis
Services
• Organic synthesis on request (small molecules/hetero-cyclic compounds)
• Hemisynthetic drugs from natural products • Chiral resolution of racemic compounds
• Full structural characterization of organic compounds (spectral analysis, elemental analysis – C, H, N, S) • Chemical library (more than 4000 in house compounds)
available for biological screening
Equipments
• Full classical organic synthesis equipment • Microwave reactor
• NMR, IR, HPLC for spectral analysis and purity control • GC for elemental analysis
• Preparative chromatography on classical and chiral columns
Contact
Bernard PirotteCIRM - Malaria
Services
Evaluation of the antiplasmodial activity of potential drugs
in vitro and in vivo
Equipments
• L2 laboratory for culture of Plasmodium falciparum (several strains with different drug sensibility) and eva-luation of drug activity
• Mice models of malaria (P. Berghei and P. Vinckei) • BEI Resources affiliated laboratory
Regulatory
Biosecurity level 2
Contact
Michel FrederichCIRM - Mass Spectrometry
Services
•
MALDI imaging of drugs and metabolites in histological slices•
Exact mass measurements•
Structural analysis using MSn•
Analysis of complex mixtures of volatiles and semi-vola-tiles•
Sequencing and fold determination of biologics inclu-ding disulfide bridges annotation•
Measurement of binding constantsEquipments
GIGA-Proteomics platform
•
QTOF Ion mobility mass spectrometers•
MALDI MS/MS•
FTICR MS•
Ion traps•
Sector instruments coupled with GC•
GC*GC-MS•
Various HPLC, nanoHPLC systems•
Adion nanomate including LESAContacts
[email protected] Gabriel Mazzucchelli [email protected] Dominique Baiwir [email protected] Nicolas Smargiasso [email protected]CIRM - Metabolomics
Services
• Metabolomic analysis of biofluids (sera, plasma, urine, …) by NMR and MS
• Metabolomic analysis of plant extracts • Metabolic profiling
• Quantification of metabolites in complex biological media
• Tissue and cell metabolomic analysis
• Structural determination of unknown metabolites
Equipments
• NMR Bruker Avance 500 MHz with a TCI Cryoprobe • Gilson sample preparator
• LC-SPE system
Regulatory
FAMPH (ISO 17025)Contacts
Pascal De Tullio [email protected] Michel Frederich [email protected] Gauthier Eppe [email protected] Jean-François Focant [email protected]CIRM - Preparative
Services
Preparative scale (gram) HPLC/CPC of mixtures using or not
CO2 extraction For
• Large scale purification • Isolation of pure enantiomers In the framework of
• Synthetic or hemi-synthetic drug production • Isolation of active products from plants
Regulatory
FAMPH (ISO 17025)
Equipments
• HPLC preparative columns packing systems (Grace ModCol® Spring®)
• Preparative CPC KROMATON (centrifugal partition chromatography)
• Preparative HPLCs + UV/DAD detector • Silica, reverse phase and chiral columns • Supercritical CO2 extractors (SUPREX)
Contacts
Michel FrederichJean-François Liegeois
