Expertise for mAbs Producers
SGS Bioanalysis / Bioequivalence Laboratories
Lab capabilities
Expertise & technologies
Regulatory compliance
5 LABORATORIES (EUROPE, NORTH AMERICA, CHINA) > 600 Projects conducted per year > 2500 Assays developed & validated > 300k Samples analyzed per year > 250 Experts > 35 Years of experience
ALL MODALITIES (NCE, NBE, ADCS, BIOSIMILARS, CGT)
GXP & CFR PART 11 COMPLIANT
• Immuno Assays: Spectramax, MSD, Luminex, Ella™,Cobas, Gyrolab, Wizard • Cell-Based Assays & Molecular Biology: Flow Cytometry, qPCR • LC-MS/MS & LC-UV-Vis/Fluorescence: Sciex, Waters, Shimadzu • Robotic: TECAN & TECAN EVOLizer (TECAN), Andrew (Waters), Extrahera (Biotage)
• US Food and Drug Administration (FDA) • European Medicines Agency (EMA) • UK Medicines and Healthcare products Regulatory Agency (MHRA) • Japan Pharmaceuticals and Medical Devices Agency (PMDA)
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