GMP Testing of Biopharmaceuticals

BSL BIOSERVICE and LPU (Labor für Pharma und Umweltanalytik; located in the vicinity of BSL) offer a broad range of physico-chemical and biological test systems for the quality control testing of Biopharmaceuticals in compliance with GMP regulations.

Analytical Support for:

 

  • Product Characterization

  • Stability Testing

  • Release Testing

    •  

     1. Active product and product related impurities

     

    General Quality
    • Container closure integrity
    • Clarity and Opalescence (Turbidity)
    • Colour
    • Extractable volume
    • pH
    • Karl Fischer (coulombmetric and direct titration)
    • Osmolality (EP, USP)
    • Particulate Matter (visible and non-visible particles)
    Quantity


            UV absorbance
    Identity, purity, integrity
    • Capillary Electrophoresis (Capillary Zone Electrophoresis (CZE); Micellar Electrokinetic Chromatography, Capillary (MEKC); Isoeletric Focusing (cIEF); SDS-PAGE)
    • SEC-HPLC
    • RP-HPLC (UV, DAD, Fluorescence, ELSD, RI)
    • IC (Ion Chromatography)
    • GC (Headspace, FID)
    • IEX (Ion Exchange)-HPLC
    • AAS, ICP-OES
    • Ligand binding assay
    Bioactivity


           Bioassay (cell-based + in vivo)
    Identity, integrity
    • Peptide mapping
    • Mass spectrometry (LC-ESI_MS; LC-MS-IT-TOF)
    • Immunoassay & ELISA
    Identity, Quantity


           Amino acid analysis
    Microbiological Quality
    • Test for sterility
    • Test for endotoxins
    • Microbial limit test

     

     

    2. Process related impurities / substances

     

    Leachables and extractables 


    GC, ICP, HPLC
    Protein A


    ELISA
    TMBP


    GC-FID