Analytical capabilities supporting a variety of product types


We have analytical capabilities and expertise that encompass a wide range of technologies to support all stages of product and process development. These have been applied to monoclonal antibodies, antibody fragments, fusion proteins, chemically conjugated proteins, hormones and enzymes. Validated analytical methods are available to support release of early phase clinical material. These methods have also been successfully used to support license applications following product specific validation.

Our analytical experience is applied to support a range of methods including:

  • Platform methods
    • CE SDS
    • icIEF
    • GP HPLC
    • Peptide mapping with UV analysis
    • Oligosaccharide profiling
    • A280 for protein conc
    • GS-CHO HCP ELISA & western blot
    • Residual DNA by qPCR
    • Residual protein A ELISA
    • Endotoxin/Bioburden
    • Specific antigen binding ELISAs
    • Enzyme assays
    • FACS based binding assays
    • Cell activation assays
    • Cell killing assays (ADCC, CDC)
    • Cell proliferation bioassay
    • Cell migration assay
    • BIAcore – receptor binding affinity and IgG Fc binding affinity
    • Batch release methods
    • Peptide mapping with UV & MS analysis 
    • N-& C-terminal sequencing 
    • Disulphide-bridge and free thiol determination
    • Intact mass electrospray LC-MS
    • Oligosaccharide profile 
    • Western blotting for product-related impurity profile compared to silver-stained gel
    • FTIR/CD
    • GMP protocoled
    • Range of container types
    • Agitation & photostability testing
    • Storage conditions:
      -65 °C and below
      -40 °C
      -20 ± 5 °C
      +5 ± 3 °C
      +25 ± 2 °C / 60 ± 5 % relative humidity (RH)
      +30 ± 2 °C / 65 ± 5 % RH
      +40 ± 2 °C/ not more than 25 % RH and +40 ± 2 °C/ 75 ± 5 % RH