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  •  Host Cell Protein characterization for CHO and E. coli-derived products.
         1. One-dimensional gel electrophoresis (SDS-PAGE, Nondenature, Fluorescence stain)
         2. Two-dimensional gel electrophoresis (2-D gel, Fluorescence stain)
         3. One-dimensional and Two-dimensional Western Blot analysis. 
         4. Host Cell Protein identification with Mass Spectrometry. 
         5. Host Cell Protein Risk assessment with Bioinformatics analysis. 
         6. Impurity analysis program strategy.
  • Host Cell Protein ELISA analysis with Certificate of Analysis (CofA) for CHO and E. coli HCPs.
  • Monoclonal antibody drug conformational comparability analysis with ELISA (Avastin; Erbitux; Campath; Rituxin; Humira; Synagis; Herceptin; any other monoclonal antibody drug or drug candidates)
  • Polyclonal antibody production.
         1. Peptide design and synthesis. 
         2. Peptide and other immunogen conjugation with carrier proteins (KLH or BSA)
         3. Antibody production (rabbits)
         4. Antibody purification (Protein A or affinity column)
         5. Antibody labeling (HRP, Biotin or molecule of interest)
  • Customer Host Cell Protein ELISA method development and validation: Develop process (or platform)-specific Host Cell Protein ELISA method and validate the method following the corresponding ICH guidelines.
  • Enzyme assays for over 850 enzymes.
  • Customer specific biosimilar conformational analysis ELISA development including the design of the antibody coverage, development of ELISA and validation of the method.