A Eurofins BioPharma Product Testing a világ legnagyobb harmonizált gyógyszeripari GMP termékvizsgáló laborhálózata, mely számos gyógyszercégnek nyújt szinte minden területre kiterjedő laboratóriumi szolgáltatásokat.
Szolgáltatási kínálatunk magában foglalja a gyógyszerhatóanyagok, a végtermékek, a köztes termékek és a kiindulási anyagok vizsgálatát mind a kis-, mind a nagymolekulájú gyógyszerek esetében.
Laboratóriumaink a GMP-nek és egyéb akkreditációknak megfelelő módszerek széles palettáját kínálja, legyen szó az Európai és Brit Gyógyszerkönyv (EP és BP), az Egyesült Államok Gyógyszerkönyve (USP) és a Japán Gyógyszerkönyv (JP) által leírt metodikákról vagy az ügyfélspecifikus módszerek implementálásáról.
Több mint 200 000 négyzetméteres globális kapacitással rendelkezünk és telephelyeink megtalálhatóak Ausztráliában, Belgiumban, Kanadában, Csehországban, Dániában, Franciaországban, Magyarországon, Németországban, Indiában, Írországban, Olaszországban, Japánban, Hollandiában, Új-Zélandon, Szlovákiában, Spanyolországban, Svédországban, Svájcban, az Egyesült Királyságban és az Egyesült Államokban. GMP-laboratóriumaink hálózata világszerte több mint 45 helyszínen azonos szigorú minőségi eljárások, LIMS és központosított számlázási rendszer szerint működik.
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Services |
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Bio/Pharmaceutical GMP Services |
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Biochemistry Services |
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Method Development & Validation |
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Residual Impurity Testing |
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Protein Characterization |
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Physico-Chemical Characterization of BioPharmaceutical Products |
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Chemistry Services |
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Extractables and Leachables |
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Container Closure Testing |
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Metals Analysis |
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Method Development and Validation |
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Impurities Testing |
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Pharmaceutical Physical/Chemical Characterization Services |
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Facility Validation Support |
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Pharmaceutical Water Testing |
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 |
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 |
 |
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 |
 |
 |
 |
 |
 |
 |
Pharmaceutical Gas Testing |
 |
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 |
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 |
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 |
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Environmental Monitoring |
 |
 |
 |
 |
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 |
 |
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 |
 |
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 |
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 |
 |
 |
 |
 |
Disinfectant Validation |
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 |
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 |
 |
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 |
 |
 |
 |
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 |
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Cleaning & Other/GMP Process Validations |
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 |
 |
 |
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 |
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 |
 |
 |
 |
 |
 |
Microbiology |
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Non-Sterile Products Testing |
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 |
 |
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 |
 |
 |
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 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
Sterility Testing |
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 |
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 |
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 |
 |
 |
 |
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Endotoxins Determination |
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 |
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 |
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 |
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Identification of Microorganisms |
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 |
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Mycoplasma Testing |
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 |
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 |
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 |
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 |
Antibiotic Potency Testing |
 |
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 |
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 |
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 |
 |
 |
 |
 |
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 |
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Calibrated Strains Production |
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 |
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Molecular & Cell Biology |
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Potency Assays / Bioassays |
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 |
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 |
 |
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 |
 |
 |
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 |
qPCR Assays |
 |
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 |
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 |
 |
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 |
 |
 |
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 |
Host Cell Protein & ELISA Assays |
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 |
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 |
 |
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 |
 |
 |
 |
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 |
Stability Storage & Testing |
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Full ICH Stability Studies |
 |
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 |
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 |
 |
 |
 |
 |
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 |
 |
 |
 |
 |
 |
 |
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 |
 |
GMP Storage |
 |
 |
 |
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 |
 |
 |
 |
 |
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 |
 |
 |
 |
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 |
 |
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 |
 |
Reference Standard Management |
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 |
 |
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 |
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 |
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Toxicology |
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Alternative Toxicology |
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 |
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 |
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 |
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Genetic Toxicology |
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 |
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 |
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 |
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Other Specialty Services |
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Viral Safety Testing |
 |
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 |
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 |
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 |
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 |
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 |
Viral Clearance |
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 |
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 |
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 |
Release Testing |
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 |
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 |
 |
 |
 |
 |
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 |
 |
 |
 |
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 |
 |
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 |
 |
Raw Materials Testing |
 |
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 |
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 |
 |
 |
 |
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 |
 |
 |
 |
 |
 |
 |
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 |
 |
Cell Bank Production |
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 |
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 |
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 |
Cell Bank Characterization |
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 |
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 |
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 |
Cell Bank Storage (LN2) |
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 |
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 |
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 |
 |
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 |
Container Testing |
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 |
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 |
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 |
 |
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 |
GMP NMR |
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 |
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 |
 |
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Custom & cGMP Radiolabeling |
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 |
Advanced Expert Analysis |
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 |
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Antimicrobial / Biocides/ Virucides |
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Efficacy Testing |
 |
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 |
 |
 |
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 |
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 |
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 |
 |
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 |
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Physico-Chemical & Analytical Studies |
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 |
 |
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 |
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 |
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Medical Devices |
 |
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 |
 |
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 |
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 |
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 |
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 |
Cosmetics |
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 |
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Chemical & Physico-Chemical Testing |
 |
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 |
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 |
 |
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 |
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 |
 |
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 |
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Microbiology |
 |
 |
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 |
 |
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 |
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 |
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 |
 |
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 |
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Safety & Efficacy Studies |
 |
 |
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 |
 |
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 |
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 |
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 |
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Human Factors Testing |
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 |
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