Eurogentec S.A. - CMOCRO

Drug Delevopment & Delivery

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Eurogentec S.A.

Eurogentec was founded in 1985 as a spin-off of the University of Liege in Belgium. Eurogentec's Biologics unit is a full-service Contract Manufacturing Organisation (CMO) delivering research, development and production services for cGMP clinical batch manufacturing.

Company Contact:

Dr. Pascal Bolon
Phone:

+32 4 366 61 16
Fax:

+32 4 364 16 04
Email:

biologics@eurogentec.com
Website:

http://www.eurogentec.com/
Address:

Rue du Bois Saint Jean 5, 4102 Seraing,

USA
Singapore
Japan
Europe
Belgium

Service Information

ANALYTICAL

API Type

Sample Type

API Container/Closure Dosage form Raw Material

Service Type

Methods Method Development Method Transfer Method Validation Process Analytical Technology Tests - Impurities/Degradation Forced Degradation Imp./Deg Quantitation Tests - Physical Particle Size Particulate Matter Tests - Protein/Peptide/DNA/Oligo Electrophoresis Elisa/Western Blot Peptide mapping Protein Aggregation/Deaggregation Protein Biophysical Characterization Protein Carbohydrate Analysis Protein Chemical Stability Protein Dosage Form Protein Primary Structure Tests - Stability Accelerated Stability ICH/Commercial Stability Storage ICH/Commercial Stability Testing Photostability Stability Storage (I/II)Stability Testing (I/II)Tests/Analysis - Other Assay/Potency Extractables/Leachables Metals Analysis Moisture Molar Extinction Coefficient Determination Residual Solvent Analysis Sample Analysis Thermal Analyses/DSC Tets - Release Lot and Batch Release Testing Wet Chemistry

API/BIOLOGICS/REAGENTS

API Development Stage

Discovery GMP clinical GMP commercial Preclinical

API Services

Biosimilar Manufacture Cell Bank Manufacturing Fermentation Process Dev.Purification Scale-up

API Types

Biologics Antibody Carbohydrate Gene/Oligos Protein Vaccine Drug Conjugates

Reagents

Intermediates PEG Reagents Reference Standards

BIO-ANALYTICAL

Services

Assays and Supplies Assay Supplies Bioassays Discovery Support Elisa/Western Blot General Methods Development and Validation Microbiology GMP-GLP Bioanalytical GMP Pre-GLP PCR

DISCOVERY/PRECLINICAL

Discovery Services

Biogenetic Proteomics Real Time PCR

Therapeutic Areas

Biologics Diagnostics Medical Devices

FACILITY REGULATORY STATUS

Facility regulatory bodies

Facility subcategories

Inspected Licensed/registered Qualified/accredited

FORMULATION/MANUFACTURING

API/Business Sector Types

Biological Peptide/Proteins

Development Stage

Formulation Discovery Formulations Formulation Development GLP/Tox Support Manufacturing GMP Clinical (Phase I/II)GMP Commercial ICH Batches Scale up Validation Batches Process Development

Formulation Type

API in Bottle Injectable Prodrugs

MICROBIOLOGICAL TESTING

Development Phase Micro

Clinical Commercial mfg Discovery Preclinical

Formulations Serviced

Biopharmaceutical Formulations Injectable Oral Veterinary

Microbiology Services

Antiseptics and Antibiotic Testing Bacterial Endotoxin Testing Bioburden Testing Microbial Identification Microbial Limit Testing Mycoplasma Testing PCR Sterility Testing Water Testing (USP)

PACKAGING/FILLING/LABELING

Development Stage

Packaging Filling Services

Aseptic/Sterile Fill

PREFORMULATION

Preformulation Services

Accelerated Stability Degredation Kinetics Forced Degradation Studies Osmolarity Particle size measurements pH-Rate profiles Protein Preformulation Solubility

REGULATORY

Formulation Category

Biopharmaceutical Formulations Injectable

Regulatory Services

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