Spectrum of Methods

Only the Best for Your Molecule

Our on-site GMP laboratories uphold the highest standards of quality as required by EMA, FDA, ANVISA, etc.

Method and Application

  • Compendial methods, e.g. visual inspection, pH, conductivity
    According to Ph. Eur./USP
  • SDS-PAGE
    Reducing, non-reducing, or native Coomassie, silver, or fluorescence staining or immunodetection for identity or purity testing
  • Isoelectric focusing
    Various staining protocols for identity or purity testing
  • Capillary electrophoresis
    Determination of residual process specific impurities, isoform pattern by IsoElectric Focusing (cIEF), or laser-induced fluorescence detection for pDNA
  • Protein quantification
    Microtiter plate and cuvette based assays such as BCA™, Bradford, and NanoOrange®
  • UV absorption
    Measurement at A280 and A260 for content determination or scanning for characterization
  • HPLC/UPLC
    Application with UV, DAD, IR, or light-scattering detection:
    • Reverse phase (RP-HPLC)
    • Size exclusion (SEC)
    • Affinity chromatography
    • Ion exchange chromatography
  • Peptide map
    Protein digestion with HPLC separation and UV detection
  • Quantification of residual DNA
    • Threshold system of molecular devices
    • Quantitative PCR
  • Quantification of host cell proteins
    • Development and characterization of mock cell line and immunization substrate
    • Generation and characterization of antibodies (immunization and purification in combination)
    • Development of HCP assay in ILA or ELISA format
  • ELISA
    Application for protein concentration or impurity testing (e.g. process related impurities)
  • Agarose gel electrophoresis
    With ethidium bromide or fluorescence staining for DNA and RNA
  • Restriction analysis
    Enzymatic digestion and agarose gel electrophoresis for identity verification
  • Quantitative PCR
    Used for:
    • Determining residual genomic DNA
    • Determining copy number by combined Q-PCR methods
    • Determining RNA
  • Quantification of RNA and DNA
    Fluorescence-based microtiter assays (e.g. PicoGreen®, RiboGreen®)
  • Replica Picking
    For determination of plasmid-retaining cells
  • Activity assays
    Cell-based or ELISA-based assays for determining potency, including statistical evaluation (e.g. proliferation or antiviral assays)